Well, welcome, everyone. Welcome to the 2021 Annual Global Meeting of the International Gynecologic Cancer Society. Oh my gosh, what a year, huh? Unfortunately, we are not in Rome, although I know it looks like it. And I was so excited to travel and was hoping to see you all there. So we're having to pivot just a bit. You may remember how eager I was for Rome in a video message that I did earlier this year. As it turns out, all roads actually lead to home, although let me tell you, that wine was awesome. But joking aside, I am glad that we can still meet and learn virtually. And I sincerely thank you all for joining us. I know we have experienced a lot of the virtual meetings lately. And I think you'll be pleasantly surprised with the upgraded features IGHS has for us this year. In the virtual networking lounge, we can actually still chat with each other in groups and one-on-one. I'll be there later as well. So I hope to see you there. Of course, we have an excellent program packed with science and education. I thank everyone who submitted abstracts and over 180 expert speakers who will be either presenting live over the next four days or who recorded sessions for us in this last several weeks. Thank you all for your contributions to the IGHS program. I'm also thankful for the tireless efforts, especially from this year's scientific program chairs, Anna Wachman and Matt Powell, their entire program committee, and of course, the IGCS staff and everyone behind the scenes at the Kennis Group, and of course, Blueprint Blue Events in Italy. They've all worked so hard at first planning a hybrid meeting and making sure that everyone would be safe in Rome and then having to make the difficult decision to shift to a fully virtual meeting once more. It's been quite a year and I know everyone is doing the very best they can in spite of the circumstances. We'd like to thank our industry partners and sponsors for your commitment to IGCS and our educational mission. Make sure you give our sponsors some attention and visit them in the virtual lobby. I was in there yesterday just to check it out. It's actually pretty cool. They have a lot of content there that I think you'll enjoy. They told us that they did not want a virtual exhibit hall this year and we listened to the feedback. I think we've all concluded that it's not the same as being face to face with us in a trade show floor. Instead, though, their presence is known in this virtual lobby and you can click on their logos and learn more about each of them. So I encourage you to check it out. So without further ado, I welcome our 2021 program chairs, Anna and Matt, to fill us in on what's in store. Thank you, Rob. It has been quite the year. We are so proud of the meeting we have planned for you. We are also grateful to everyone who switched gear for a hybrid meeting to virtual. As Rob mentioned, a big thank you is due for the program committee. I enjoy working with everyone and they all play a part in the success of the final program. From grading abstracts to sharing sessions and getting expert speakers to join us. We really owe so much on current directors and moderators and I thank each of you for your commitment to women's cancer and giving so freely of your time. Now just the meeting is virtual, it doesn't mean you cannot be heard. Members of the live session will have opportunities for audience participation through question and answer segments and polling. So please feel free to ask questions with the chat feature during the session. And in the virtual networking lunch, we'll have public chats dedicated to some of the most controversial topics. So if you have an opinion, a comment or question about anything you hear, please go there to talk about it. We're also being used in social media, particularly Twitter, to amplify the thought of you at home. If you tweet sorry, please include hashtag IGCS 2021 in your post and it will appear on the Twitter wall right here in the meeting platform. If you hear something interesting during the meeting, please share it. The more you tweet, the more chances you have to win a prize. We also want to see how you are experiencing the meeting. Are you at home with kids and pets in your office or watching with a group? Take a picture of your setup and tweet it with hashtag IGCS 2021. We'll select a photo content winner each day. Yes, indeed, Anna. We all know Rob Coleman will be submitting lots and lots of pictures, so everybody can compete with Rob. I'd love to see how some of you are experiencing the meeting and hear what you think of the program. Anna and I and Rob have spent a lot of time getting this together and we're so excited. Consistent with all IGCS meetings this year, we'll hear about the latest clinical advances and international developments in research, practice, treatment for the care of women affected by gynecologic cancer. There's one master session each day where we'll cover each disease in depth. I think you'll find these to be amazing sessions. We really put together a great group of speakers this year. Then there's six debates, including surgical debates and 11 postgraduate courses on a variety of topics that are really cutting edge. I think you really can't go wrong with any of these sessions. All of the concurrent educational programming will run in three live virtual halls. I think if you've had time to explore how the system works, you'll see it's very intuitive. Recordings of each of the sessions will be available on demand in the on-demand hall about 24 hours after taking place. In addition to the scheduled programs, we're thrilled to offer 24-hour access to this virtual meeting site where you can find the surgical film cinema with 22 films, the abstract poster hall with over 300 posters and audio files where the authors further explain their research in great detail. In the poster hall, you can also leave comments for the author or send them questions. Really an interactive abstract poster hall that really should be quite nice to really allow the presenters to expand the interaction with all of us. And then of course, there is the networking lounge that Anna and Rob mentioned earlier. If you visit the list of delegates from the lobby, you can see who's here and search for your friends. You can find detailed tutorial here on the site that explains the features. And if you're experiencing any technical difficulties or need any help, please use the support chat at the bottom right of your screen. This site will remain open for 90 days after the meeting until December 4th, so you can watch recordings and view everything in your own time. Make sure to take advantage of all the features and check out all the education. And thank you all for being here with us and enjoy the meeting. Wow, that's fantastic, you guys. I have to admit, I was playing around in the virtual lobby in the various different areas. It's actually pretty nice. The interfaces, I think you'll be pleased with the interface this year. It's really been upgraded and there's a lot of content there. And it's pretty easy to navigate. I was able to make it through pretty easily, so I encourage you to go there. So on behalf of the IGCS Council and the entire membership, thank you again, Anna and Matt. Your work here has just been incredible. The program is outstanding and society is indebted to you both. You know, as much as we all want to get back to a meeting in person, it's a great time that we have these virtual sessions, solutions to share our research, learn and gather inspiration for the sake of caring for our patients. It's always the bottom line. I can't wait to see what's in store over the next four days and even more excited that I have 90 days to watch it all continuously. With that being said, this now concludes the opening ceremony and I'll hand it back over to Anna and Matt to introduce our first abstract presenters. Have a great meeting, everyone, and I hope to see you here again soon. Thank you so much, Ru. I'm very, very happy to say that we have an incredible lineup of abstract presentations for this session. So let's get started. First up, we'll hear from the well-known Professor Chris Tewari. So I don't want to have any kind of delay, a long introduction. So I will turn the screen to Professor Tewari now to present his abstract. Please, Professor Tewari, go ahead. Thank you, Anna. I'm just getting this set up here again, presenter view. Hello and good morning. I'm Dr. Krishnansu Tewari from the University of California, Irvine. On behalf of my co-investigators and co-authors, I'm honored to present Empower Cervical One GOG3016 NGOT Cervix 9, results of a phase three trial of simplumab versus investigators' choice chemotherapy in recurrent and metastatic cervical carcinoma. I'd like to thank Dr. Coleman, Dr. Oakman, Dr. Powell, and the IGCS organizers for this opportunity to share these important data from our study, which was sponsored by Regeneron and Sanofi. All right, here are my disclosures. The slides are available and they can be reviewed later. Cervical cancer is the fourth leading cause of death amongst women. First-line treatment of these patients is associated with median overall survival no better than 18 months, and second-line options are limited. To date, no therapy has demonstrated a survival benefit beyond first-line therapy. Simplumab is a high-affinity human hinge-stabilized IgG4 monoclonal antibody to the PD-1 receptor. We conducted an open-label, randomized phase three study of simplumab versus investigators' choice chemotherapy in patients with recurrent or metastatic cervical cancer that had progressed after platinum-containing chemotherapy. Our study enrolled 608 adult patients regardless of PD-L1 expression. 477 had squamous cell cancers, 131 had adenocarcinoma, and this also included adenosquamous tumors. Patients were stratified by tumor histology, geographic region, prior bevacizumab use, and ECOG performance status score. Patients were randomized one-to-one to either simplumab, given at a flat dose of 350 milligrams every three weeks intravenously, or investigators' choice chemotherapy. Patients in both arms were treated up to 96 weeks with option for retreatment. The primary endpoint was overall survival. Secondary endpoints included progression-free survival, objective response rate, duration of response, safety, and quality of life. Two interim analyses were pre-specified per the protocol. At the second interim analysis, the Independent Data Monitoring Committee recommended the trial close early for efficacy based on a significant improvement in overall survival for simplumab versus investigators' choice chemotherapy in patients with squamous cell carcinoma. Today I'll be showing you the results of this analysis. The data cutoff date was January 4th of this year. Here are some key assumptions included in our statistical analysis plan. To yield approximately 90% power to detect a hazard ratio of death of 0.7, a total of 340 overall survival events would need to occur and lead to the planned sample size of 590. A hierarchical testing strategy was pre-specified for confirmatory analysis of primary and secondary endpoints. The order of statistical testing is shown on the right, with the primary endpoint of overall survival in squamous cell carcinoma patients being analyzed first. The patient demographics and baseline characteristics of the 608 randomized patients were well-balanced between the simplumab and chemotherapy arms. Here are the data which led to the IDMC recommendation to stop our trial early. Median overall survival with chemotherapy was 8.8 months versus 11.1 months with simplumab in squamous cell carcinoma patients. The hazard ratio for death was 0.73. In this first step of the hierarchical analysis, the superiority of simplumab over chemotherapy in improving overall survival is apparent and significant in this population of squamous cell carcinoma. Please note the median duration of follow-up of 16.8 months in this population. Here we show the second step of the statistical hierarchy, overall survival in the overall population. The median overall survival was 8.5 months with chemotherapy versus 12 months with simplumab. Overall survival was significantly longer with simplumab versus chemotherapy with a hazard ratio of death of 0.69. While not part of the hierarchy, survival in the adenocarcinoma population was consistent with that in the overall and squamous cell carcinoma populations. Median overall survival was 7.0 months with chemotherapy versus 13.3 months with simplumab in the adenocarcinoma population, and the hazard ratio for death was 0.56. In addition to tumor histology subgroups, the benefit of simplumab over chemotherapy in improving survival was also seen in the pre-specified subgroup analyses of geographic region, ECOG performance status, status with respect to prior bevacizumab use, and the number of prior lines of systemic therapy as depicted in this forest plot. Let's turn now to patient-reported outcomes. In the overall population, a nominally significant difference in overall mean change from baseline in global health status quality of life scale was observed in favor of simplumab over chemotherapy. Patients receiving simplumab generally improved or maintained global health scale quality of life from baseline, while those on chemotherapy generally deteriorated. Of the 608 randomized patients, 254 had valid baseline PD-L1 samples, 126 from the Simplumab arm and 128 from the chemotherapy arm. Simplumab-treated patients with PD-L1 expression of at least 1% showed an enhancement of survival benefit. Moreover, Simplumab-treated patients with PD-L1 expression less than 1% demonstrated a survival benefit either comparable to or slightly better than chemotherapy. The additional analysis of PD-L1 expression and efficacy showed that Simplumab improved median overall survival versus chemotherapy in the overall population regardless of tumor cell PD-L1 status. Similar findings were observed with progression-free survival and objective response. Simplumab had a longer median duration of exposure of 15.2 weeks versus 10.1 weeks with chemotherapy. As shown on the slide here, when incidence rates of adverse events are normalized for duration of exposure, the difference between the safety profiles of Simplumab versus chemotherapy become more apparent. Immune-related adverse events occurred in 16% of patients in the Simplumab arm and in 0.7% of patients in the chemotherapy arm. Of note, no new immune-related adverse events were identified. Adverse events that led to death occurred in 1.7% of patients treated with Simplumab and 0.7% of patients treated with chemotherapy. None of the events leading to death were considered related to treatment with Simplumab. The safety profile of Simplumab in this trial was consistent with the previously reported profile for Simplumab and other PD-1 and PD-L1 inhibitors in other tumor types and is favorable compared to chemotherapy. To summarize, in this, the largest randomized study conducted to date in this population, Simplumab is the first immunotherapy to demonstrate a statistically significant and clinically meaningful survival benefit in recurrent and metastatic cervical cancer following progression after first-line platinum-containing chemotherapy. The median overall survival with Simplumab versus investigator's choice chemotherapy was 11.1 months versus 8.8 months respectively in the squamous cell carcinoma population. Simplumab also demonstrated survival and objective response benefits in the overall and adenocarcinoma populations. Patients in this study were enrolled without regard to PD-L1 positivity. A numerical overall survival benefit for Simplumab versus investigator's choice chemotherapy was seen in patients with PD-L1 less than 1%, although the benefit was larger in patients with PD-L1 greater than or equal to 1%. The safety profile of Simplumab in this study was consistent with those in previously studied tumor types. No new safety signals were observed and changes in global health status quality of life directionally favored Simplumab. Taken together, Simplumab can provide a new standard of care treatment option for this population which has been associated with a very poor prognosis. On behalf of my co-authors, we'd like to thank the patients, their families, the investigators and investigator site members across the globe for their commitment to advancing management of cervical cancer. We want to also thank again the IDCS organizers for this opportunity to share these important data from our study. We look forward to further discussing these data and any questions you may have. Thank you. Thank you, Dr. Tiwari. Incredible study and congratulations on your work. And I really point out thanking you for staying on time. That'll be our theme for the meeting. Also want to point out to everybody listening, please feel free to use the chat function. We don't have a question and answer session as part of this opening ceremony, but the chats will be answered by the authors. Next up, we have Dr. Vicky Mocker. Dr. Mocker, please share your screen and we anxiously await your presentation. Hello, everyone. It's wonderful joining everyone virtually today during these uncertain times. And on behalf of my co-authors, I would like to thank the IGCS organizing and selection committees for affording me the opportunity to present results of a study 309, Keynote 775, a randomized phase three study of lenbatinib plus pembrolizumab for advanced endometrial cancer, subgroup analysis of patients with DNA mismatch repair deficient tumors. Here are my disclosures. So as we know, there continues to be a tremendous unmet need for the development of effective therapies for advanced recurrent endometrial cancer and no global standard second line treatment following platinum-based chemotherapy as yet has been identified. Checkpoint inhibitors have previously shown benefit in MSI high or mismatch repair deficient tumors where deep and durable responses have been evinced. Study 309, Keynote 775 is an open label randomized phase three study to compare the efficacy and safety of lenbatinib or LEN in combination with pembrolizumab or PEMBRO versus treatment of physician's choice or TPC in patients with advanced endometrial cancer. And in this study, LEN plus PEMBRO showed statistically significant and clinically meaningful improvements in overall survival, progression-free survival and objective response rate versus TPC in MMR proficient and all comer populations with advanced endometrial cancer following platinum-based chemotherapy. In this study, LEN plus PEMBRO also had a manageable safety profile that was generally consistent with established safety profiles of the individual monotherapies. Now, as approximately 16 to 31% of endometrial cancers are MSI high or mismatch repair deficient, we analyzed the DMMR subgroup of patients with advanced endometrial cancer treated on study 309, Keynote 775 and report results of this important subtype here. Key eligibility criteria included advanced metastatic or recurrent endometrial cancer with measurable disease per resist 1.1 per blinded independent central review. Patients had to have one, but were allowed two prior lines of platinum-based therapy if one was administered in the neoadjuvant or adjuvant setting. Patients were stratified by MMR status and within the MMR proficient cohort were further stratified by region, ECOG status and prior history of pelvic radiation. Eligible patients were randomized one-to-one to LEN 20 milligrams orally once daily plus PEMBRO 200 milligrams IVQ three weeks versus TPC of doxorubicin 60 milligrams per meter squared IVQ three weeks or Paclitaxel 80 milligrams per meter squared IV weekly three weeks on one week off. PEMBRO could be administered for a maximum of 35 doses with LEN continuing beyond that point if a patient was clinically benefiting. And the maximum cumulative dose of doxorubicin allowed on study was 500 milligrams per meter squared. Primary endpoints were progression-free survival by BIKR and overall survival and secondary endpoints included objective response rate and quality of life analyses. Key exploratory endpoint was duration of response. Pre-specified exploratory endpoints for the DMMR population included PFS, OS, objective response rate and duration of response as well as assessment of safety. A graphical approach from multiplicity to control for type one error was utilized to test PFS first in PMMR and then all comers cohorts followed by overall survival and objective response rate for PMMR patients and then all comers which included the DMMR patients. The first interim analysis which detailed the final PFS and interim OS was triggered by approximately 368 OS events in the PMMR patients with greater than or equal to six months of follow-up. Data cutoff for IA1 occurred approximately 8.5 months after the last patient was randomized. PFS and OS were evaluated using a stratified log-rank test. Hazard ratios were evaluated by Cox proportion hazard model. Power calculations were based on the MMR proficient population and exploratory analyses were conducted in the MMR deficient population. Here we see baseline characteristics for the DMMR population. 65 DMMR patients were randomized to each treatment arm. 52% of patients in both arms had ECOG zero. Most patients in both arms were white. Nearly 20% of patients in both arms were Asian. Black patients comprised three and 8% of patients on Lenpembro versus TPC. As expected, approximately 85% of patients on both arms were endometrioid histology and the breakdown by FIGO grade is shown in the slide. Within the Lenpembro arm, 6% of patients were serous or of mixed histology and within the TPC arm, approximately 5% of patients were serous or of mixed histology. Nearly 90% of patients in both arms received one prior line of platinum-based treatment and 42 versus 49% of patients on Lenpembro versus TPC received prior neoadjuvant and or adjuvant treatment. Within the DMMR population, statistically significant improvements in PFS and OS were seen with Lenpembro compared to TPC. The median PFS for the DMMR cohort was 10.7 versus 3.7 months for Lenpembro versus TPC respectively with a hazard ratio of 0.36. As was seen for the PMMR population, the PFS curves in the DMMR cohort separate early and at approximately the first radiologic assessment. Despite informal crossover when Lenpembro became approved in many countries based on Keynote 146 results in September of 2019, with a median follow-up of 12 months, overall survival for the DMMR cohort was not breached versus 8.6 months for Lenpembro versus TPC with a hazard ratio of 0.37. Again, the OS curves separate early and well before the three-month mark. In the DMMR cohort, the objective response rate was 40 versus 12% for Lenpembro versus TPC. CR and PR rates were approximately tripled for Lenpembro versus TPC. Complete response rate was 14 versus 3%. Partial response rate was 26 versus 9%. Twice as many patients experienced progressive disease on TPC versus Lenpembro. Median duration of response in the DMMR cohort was not breached versus 4.1 months for Lenpembro versus TPC. Median time to response in the DMMR cohort was 2.9 versus 1.9 months for Lenpembro versus TPC. And disease control rate was 74% versus 48% for Lenpembro versus TPC. Within the DMMR cohort, the median duration of treatment was almost four times longer for Lenpembro at 336 days versus 86 days for TPC. Grade 3 or greater treatment emergent adverse events occurred in 95 versus 73% of patients on Lenpembro versus TPC. Len dose reduction occurred in 64% versus 13% of patients on TPC. Study drug interruption occurred in 72% of patients on Lenpembro versus 22% of patients on TPC. Len was interrupted in 61%, Pembro in 59%, and both were interrupted in 39% of patients. Study drug discontinuation occurred in 44% of patients on Lenpembro versus 6% of patients on TPC. Len was discontinued in 44%, Pembro in 25%, and both were discontinued in 22% of patients. The most common NE grade TEAEs for Lenpembro were hypothyroidism in 69% of patients and hypertension in 56% of patients, followed by diarrhea, nausea, and decreased appetite, each of which occurred in approximately 50% of patients, whereas with TPC, anemia, nausea, neutropenia, and asthenia were most common. In conclusion, in study 309, keynote 775, the efficacy in the DMMR population of patients with advanced endometrial cancer appeared to improve with Lenpembro, at least consistent with that of patients in both the PMMR and all comers populations, and this was previously reported. PFS, OS, and objective response rates were improved with Lenpembro compared to treatment of physician's choice. Notably, approximately 14% of patients treated with Lenpembro in this pretreated population had a complete response, and lendatinib plus pembrolizumab had a manageable safety profile in the DMMR population that was generally consistent with that observed in the all comers population and the established safety profiles of the individual monotherapies. My co-authors and I would like to express our deepest gratitude to all patients and their families, as well as to all the investigative teams who participated in this study. Thank you very much. Thank you, Dr. Maeker, for what an excellent presentation, and so exciting to have this cutting-edge work being presented here at our meeting, and again, please feel free to comment through the chat function with questions and really making this an interactive session. We will now hear from Dr. Anna Ochten for her study. Anna, please go ahead. Thank you, Matt. Hello, everyone around the world. I'm very happy to be with you all virtually. Firstly, I would like to thank the IGCS Scientific Committee for allowing me to present today on behalf of my co-author the anti-tumor activity of the Starlimab in patients with advanced or recurrent measurement repair deficiency of proficient cancer by prior therapy, results from the GARNET study. This is my disclosures. Endometrial cancer is the most common gynecological malignancy in North America and Europe, and remarkably, 30% of endometrial cancer are measurement repair deficient, or MSI-high tumors. Indeed, these DMR MSI-high tumors present a high expression of neoantigens, making them more likely to respond to anti-PD-1 therapies. The Starlimab is anti-PD-1 monoclonal antibody approved in the EU and US for patients with DMR endometrial cancer that has progressed after a platinum-containing regimen. These Dostarlimab approvals were based on the data from the ongoing Phase 1 GARNET study. In Parts 1 and 2a of the study, the recommended therapeutic dose of Dostarlimab was established as 500 mg every three weeks for four cycles and then 1,000 mg every six weeks until disease progression or discontinuation. This dose was used in Part 2b, namely the expansion cohort. Data presented today are from the two endometrial cancer cohorts, A1 and A2. The primary endpoint of the trial were objective response rate and durational response. As the data cutoff date, we define two populations. There are 129 DMMR MSI-high patients and 161 mismatch repair proficiency MSS patients enrolled and treated. These make up the safety population. For the efficacy population, only patients with at least 24 weeks of follow-up time in the study and with at least one measurable ratio at baseline were included for this interning analysis. Here, we show the baseline characteristics of the efficacy populations. The most notable difference between the two cohorts is that endometrioid carcinoma, Grade 1 or Grade 2, was the most common histology in the DMMR MSI-high cohort, whereas the majority of patients in the mismatch repair proficiency MSS cohort had Type 2 endometrial carcinoma, with serous histology being the most common. All patients had at least one prior line of platinum-based doublet chemotherapy. In the DMMR cohort, 63% had received only one line, whereas in the mismatch repair proficiency cohort, 54% had received two or more lines of therapy. Well, when we look at the response rates according to the number of previous lines, for patients with DMMR MSI-high endometrial cancer, the objective responses were higher in patients with one prior line of therapy, 50%, compared with patients who had two or more prior lines of therapy, 36%. The disease control rate was also higher in patients with only one prior line. However, it should be noted that the study was not powered to detect a difference between these subgroups. Moreover, the median duration of response had not yet been reached for either subgroup. Looking at the mismatch repair MSS endometrial cancer cohort, response rate and disease control rate for those patients were similar, regardless of number of prior lines of therapy. And once again, the median duration of response had not yet been reached for either subgroup. In terms of durational response, these swimmer lanes show the time since the start of treatment for patients with DMMR MSI-high endometrial cancer. As you can see, the responses were durable, regardless of the number of prior lines of therapy, and 88% of the responders with one prior line remaining in response, and 93% of responders with two or more prior lines remaining in response at the time of the data cutoff. For those patients with mismatch repair proficiency MSS tumor, again, responses were durable, with 70% of responders with one prior line, and 67% of patients with two or more prior lines of therapy remaining in response as of the data cutoff. What about safety? In regards to safety, Doster-Limath was well tolerated, with an adverse event profile characteristics of anti-PD-1 agents. While nearly all patients experienced at least one adverse event of any grade, less than 20% of patients in either cohort experienced a grade 3 or greater adverse event that was considered as related to Doster-Limath. The discontinuation rate was 30.9% in the DMMR MSI- high patients, and 6.8% in the mismatch repair proficiency MSS, or 5.5% collectively. The most common treatment-related adverse events were fatigue, diarrhea, nausea, and asthenia, and the most common grade 3 or greater adverse events were anemia, ALT increase, diarrhea, fatigue, amylase, and lipase increase. No deaths were attributed to Doster-Limath. The overall incidence of immune-related adverse events was low, with hypothyroidism being the most common anti-grade immuno-related treatment-related adverse event. The most common grade 3 or greater immuno-related treatment-related adverse events were ALT increase, diarrhea, and amylase, and lipase increase. So, in conclusion, Doster-Limath demonstrated durable anti-tumor activity in both DMMR MSI-high and mismatch repair proficiency MSS advanced or recurrent endometrial cancer. While Doster-Limath has shown anti-tumor activity regardless of number of previous lines of therapy, in patients with DMMR MSI-high endometrial cancer, overall response rate was higher in patients with one prior line than in patients with two or more prior lines. Patients with DMMR MSI-high tumor showed a higher overall response rate than patients with mismatch proficiency MSS tumor. And finally, Doster-Limath has an acceptable safety profile with manageable adverse events in the endometrial cancer safety population of the GARNET trial. Lastly, I'd like to thank the patients and their families, as well as the GARNET trial investigator and the support staff at each site. Thank you for your attention. I am your sponsor for any questions that you may have. Thank you again. Well, congratulations on your study and presentation, Ana, Dr. Arquette. Just wonderful to see this cutting-edge science at our meeting. I now invite Dr. Antonio Gonzalez-Martin to join us for a distillation on these three important abstract presentations. Antonio, please proceed. And again, please use the chat function to submit questions. So, thank you. I would like to thank the scientific committee for giving me the opportunity for the distillation of the three abstracts presented at the first plenary oral session. These are my disclosures. It's my honor to discuss the data presented today from three practice-changing clinical trials, two in endometrial cancer and one in cervical cancer. How is the landscape in advanced endometrial cancer? Systemic therapy for advanced recurrent disease with platinum-based chemotherapy is of limited efficacy, and no standard second-line therapy has been identified. MMR deficiency or MSI high is a predictive biomarker for checkpoint inhibitors activity. This table summarizes the results already communicated of the two trials on endometrial cancer presented today. In keynote 775, the investigator showed for the first time a clinically significant benefit in overall survival and progression-free survival with a combination of limbatinib and pembrolizumab for endometrial cancer patients previously treated with platinum. These results led to regular FDA approval of the combination in July this year for patients with non-MSI high or mismatch repair-deficient tumors, and the approval in Europe is expected soon. On the right, garnet was a phase 1-2 study that showed an impressive overall response rate and duration of response with dostarlimab in platinum pre-treated patients with mismatch repair-deficiency or MSI high tumors that granted accelerated approval by FDA and conditional market approval by EMA. Today, both trials have presented new data that have raised relevant questions. Keynote 775 has presented data on the mismatch repair-deficient population, and the question is if the combination of checkpoint inhibitor and tyrosine kinase inhibitor is necessary for this biomarker subtype. Garnet has presented the activity of dostarlimab to the number of prior lines, and the question is when to introduce checkpoint inhibitors in the patient history with endometrial cancer and mismatch repair-deficiency. Regarding the first question, there is only one small randomized phase 2 presented this year in ASCO that showed a better progression for survival with the combination of cabosantinib and nivolumab compared with nivolumab, but only 2% of the patients were MSI high. In this table, you can see summarized the new data presented today by the Keynote 775 investigators. The combination has shown clear improvement in progression-free survival and overall survival for the mismatch repair-deficient population, although this analysis was exploratory and not enough power. Overall response rate, the complete response rate, and duration of response were impressive and similar to those observed with pembrolizumab monotherapy in the Keynote 158 or dostarlimab in the Garnet study. Safety is still an issue, and discontinuation rate was 44% for lembatinib and 22% for both compared with dostarlimab in Garnet that was 4% or pembrolizumab alone in the Keynote 158 that was 9%. We could conclude that single agent checkpoint inhibitor offers an excellent efficacy and safety profile for patients with MMR deficient or MSI high advanced or recurrent endometrial cancer, and the combination with TKI is not clearly justified for this population. Moving to the next study, the sub-analysis presented today by the investigators of Garnet has shown a higher overall response rate in mismatch repair-deficient endometrial cancer patients with one prior line versus two or more, no clear difference in the MMR proficient group of patients. Although this is an exploratory analysis with a limited number of patients, we could hypothesize that checkpoint inhibitors should be moved to earlier lines, at least for the mismatch repair-deficient group of patients. In this regard, this table shows the main randomized studies including checkpoint inhibitors in the first line of the adjuvant setting. Of note, two trials, DOMENICA and the GOG3064-NGOT-EM15 are comparing single agent checkpoint inhibitor versus standard chemotherapy in the front line of patients with MMR deficient tumors. Moving to the last trial presented today in cervical cancer, second line chemotherapy is rarely effective after platinum-based front-line chemotherapy and there is no standard of care in second line. Based on the cervical cancer biology, there is a strong rationale for immune therapy with checkpoint inhibitors. Empower-1 compares Implimab with investigator choice chemotherapy in patients with recurring or metastatic cervical cancer resistant to platinum and showed for the first time a significant improvement in overall survival, the primary endpoint, in the second line of the patients with the scamule cell carcinoma and in the total population. In addition, it was shown an improvement in the overall survival for the adenocarcinoma patient that was an exploratory endpoint and in the quality of life that was a key secondary endpoint. When we observed the Kaplan-Meijer survival curves for progression-free survival and overall survival, we realized that the curves come together initially and they separate after several months. How could we improve the performance of checkpoint inhibitors in cervical cancer? One possibility is to combine with chemotherapy or with other I.O. Another option is to find biomarkers for a better selection of patients. Dr. Tewari has shown today the survival analysis according to the PD-L1 expression. For this analysis, there was a valid sample for PD-L1 assessment in 254 out of 608 patients, which may limit the conclusions. Nevertheless, in this analysis, patients with tumor cell PD-L1 positivity had better overall survival in both arms in comparison with the PD-L1 negative. In addition, it seems that the benefit of semiplimab is much clearer in the population that is PD-L1 positive, but if PD-L1 has a prognostic or a predictive value, it should be validated. And this hypothesis is worth to be analyzed in the randomized clinical trials incorporating checkpoint inhibitors to the standard frontline recurrent metastatic or persistent cervical cancer and in the trials with checkpoint inhibitors in locally advanced cervical cancer. In conclusion, I would like to congratulate the principal investigators, sponsors, clinical trials group, and individual research teams for these practice changing trials that bring light at the end of the tunnel for many of our patients. Thank you very much. Thank you, Dr. Gonzales-Martin, for that excellent distillation and all amazing presenters today for sharing their amazing work. This concludes our opening plenary session. Up next in this hall, we have a debate, a debate your colleagues session featuring too many debates on endometrial and cervical cancer, or you can visit the hall two for a surgical film session on ovarian cancer, or in addition, visit hall three for a session on developing HIPAC program led by Dr. Guntupalli. These sessions will begin in about 10 minutes, so we'll see you then and everybody, please enjoy the meeting and please keep us updated if there's anything we can do better. Ciao.

IGCS

virtual meeting

Simplimumab

chemotherapy

squamous cell carcinoma

Keynote 775 trial

Lenvatinib

Pembrolizumab