(Press-News.org) Philadelphia, PA, USA, December 9, 2025, First Patient Enrolled in GOG-3133/ FRAmework-01 Phase 3 Study Evaluating Sofetabart Mipitecan (LY4170156), a Novel ADC Targeting Folate Receptor Alpha (FRα), in Recurrent Ovarian Cancer
The GOG Foundation, Inc. is proud to announce the enrollment of the first patient in GOG-3133, a pivotal Phase 3 clinical trial titled FRAmework-01: A Two-Part Phase 3 Study of LY4170156 versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and LY4170156 plus Bevacizumab versus Platinum-Based Chemotherapy plus Bevacizumab in Platinum-Sensitive Ovarian Cancer. The study is sponsored by Eli Lilly and Company and conducted in collaboration with The GOG Foundation, Inc.
Dr. Roisin O’Cearbhaill, Principal Investigator and gynecologic medical oncologist at Memorial Sloan Kettering Cancer Center, stated: “We’re pleased to announce the first patient enrollment in GOG-3133, a randomized phase 3 study evaluating sofetabart mipitecan, a novel folate receptor alpha-targeting antibody-drug conjugate. This is an important step forward in expanding treatment options for recurrent ovarian cancer.”
Sofetabart mipitecan is a novel folate receptor alpha-targeting antibody-drug conjugate featuring an exatecan payload. In early-phase studies, sofetabart mipitecan demonstrated robust and durable clinical activity with an ORR of 50% among 104 heavily pre-treated patients (median prior lines=5) with platinum-resistant ovarian cancer (PROC), across all range of FRα expression levels, and in patients previously treated with mirvetuximab soravtansine with negligible rates of interstitial lung disease and peripheral neuropathy and no ocular toxicity or alopecia[1].
This clinical trial has two parts; it tests a potential new medicine called sofetabart mipitecan for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A looks at participants whose cancer no longer responds to platinum-based chemotherapy (platinum resistant). Part B looks at participants whose cancer has a higher chance of responding to platinum-based chemotherapy (platinum sensitive). Dr. Bhavana Pothuri, Principal Investigator at NYU Langone Health, Perlmutter Cancer Center notes, “This is potentially exciting for patients who have platinum sensitive disease and progress on or within 6 months of treatment with a PARP inhibitor as these patients may have a diminished response to re-treatment with platinum- based chemotherapy.” Researchers want to determine if sofetabart mipitecan has better activity than the current (or standard) treatments used now and to better understand safety. Each participant's time in the study will depend on how they respond to the treatment.[2]
This trial exemplifies the power of collaboration between academic institutions, clinical research networks, community sites, and industry partners. The FRAmework-01 study aims to address the need for more effective therapies in both platinum-resistant and platinum-sensitive ovarian cancer. Thomas Herzog, President of The GOG Foundation, Inc., commented: “Our partnership with Lilly reflects a shared commitment to transforming the standard of care in gynecologic oncology. Through GOG-3133, we aim to bring forward innovative, targeted therapies that may improve survival and the quality of life for individuals with recurrent ovarian cancer.”
Platinum-resistant ovarian cancer presents a therapeutic challenge and remains an unmet medical need. In a recent New England Journal of Medicine publication, patients with FRα-positive, platinum-resistant ovarian cancer treated with standard chemotherapy had a median progression-free survival (PFS) of 3.98 months and an objective response rate of 15.9%. Patients who are FRα high have experienced improved outcomes with mirvetuximab soravtansine, but only approximately 35% of ovarian cancer patients are eligible for treatment with mirvetuximab.2 The development of novel FRα ADCs like sofetabart mipitecan may represent an important step toward addressing unmet needs in ovarian cancer treatment, potentially expanding effective and tolerable options for patients regardless of their tumor FRα expression levels.
Since the approval of bevacizumab in 2016, the only FDA approvals for platinum-sensitive ovarian cancer have been PARP inhibitors in the maintenance setting and with restrictions for BRCA mutations or HRD-positive tumors. FRAmework-01 may change this if results demonstrate that sofetabart mipitecan plus bevacizumab improves outcomes for platinum-sensitive ovarian cancer patients without the high side effect burden of platinum-based chemotherapy and especially in patients who may have progressed on or within six months of PARP inhibitor use.
The GOG Foundation has been a leader in gynecologic oncology research for over five decades, with a mission to advance clinical trials and improve outcomes for patients. Under Dr. Herzog’s leadership, the Foundation continues to expand its reach and impact through initiatives focused on inclusion, international collaboration, and mentorship of emerging investigators.
Dr. O’Cearbhaill has financial interests related to Loxo Oncology, subsidiary of Eli Lilly and Company.
Dr. Pothuri has a compensated role as Clinical Trial Advisor, GOG Partners and Director of Clinical Trials Access, with The GOG Foundation, Inc.
Dr. Herzog has a compensated role as President, with The GOG Foundation, Inc.
About Ovarian Cancer
Ovarian cancer is the eighth leading cause of cancer-related death among women worldwide. In 2020, GLOBOCAN estimated 314,000 women received a new diagnosis of ovarian cancer, and approximately 207,200 women died from ovarian cancer. According to the American Cancer Society, an estimated more than 20,500 women will be diagnosed with ovarian cancer in the United States, and there will be an estimated nearly 13,000 deaths from ovarian cancer in 2025. [3] According to GLOBOCAN, an estimated 66,000 women in Europe are diagnosed each year with ovarian cancer, and ovarian cancer is among those cancers with the highest rate of death. According to the NIH National Cancer Institute, more than 75% of women are diagnosed with ovarian cancer at an advanced stage. Despite recent advances in the therapeutic landscape of newly diagnosed ovarian cancer, advanced ovarian cancer is still considered incurable for the majority of patients, and the optimal treatment strategy has yet to be determined.[i] Although most respond initially to this treatment, 80% of patients with advanced ovarian cancer will have a recurrence and require subsequent therapies.
About The GOG Foundation, Inc. (www.gog.org)
The GOG Foundation, Inc. is a not-for-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and translational scientific research in the field of gynecologic oncology. The GOG Foundation is committed to maintaining the highest standards in clinical trial development, execution, analysis, and distribution of results. The GOG Foundation is the only clinical trialist group in the United States that focuses its research on patients with pelvic malignancies, such as cancer of the ovary (including surface peritoneal malignancies), uterus (including endometrium, soft tissue sarcoma, and gestational trophoblastic neoplasia), cervix, and vulva. The GOG Foundation is multi-disciplinary in its approach to clinical trials, and includes gynecologic oncologists, medical oncologists, pathologists, radiation oncologists, oncology nurses, biostatisticians (including those with expertise in bioinformatics), basic scientists, quality of life experts, data managers, and administrative personnel.
About the GOG Partners Program
Supported by industry, GOG Partners program is structured to work directly with pharmaceutical organizations and operate clinical trials outside the National Cancer Institute (NCI) framework. The GOG Partners program promotes the mission of the GOG Foundation dedicated to transforming the care in gynecologic oncology. By providing an alternative venue for patient accrual and site infrastructure support, GOG Partners has helped provide additional trials and opportunities for patients outside the national gynecologic clinical trials network and has led to several FDA approvals.
Corporate & Media Contact:
GOG Partners
Jenna Cummins, CMP, Executive Director of Business Development
773-750-5753, jcummins@gog.org
[1] Ray-Coquard, Isabelle, et al. (2025, October 17-21). Results from the first-in-human phase 1 study of LY4170156, an antibody drug conjugate (ADC) targeting folate receptor alpha (FRα) in recurrent platinum resistant high-grade serous ovarian cancer (HGSOC) [Poster Session]. ESMO 2025, Berlin, Germany
[2] https://www.clinicaltrials.gov/study/NCT07213804
[3] https://www.cancer.org/cancer/types/ovarian-cancer/key-statistics.html
END
First patient enrolled in GOG-3133/ FRAmework-01 phase 3 study evaluating sofetabart mipitecan (LY4170156), a novel ADC targeting folate receptor alpha (FRα), in recurrent ovarian cancer
2025-12-09
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