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PUBLICATION

The post The GOG Foundation and EVA/LACOG Partnership: A Collaborative Strategic Alliance for Clinical Trial Execution Publication appeared first on GOG.

PUBLICATION

Expanding the workforce of clinical trial investigators committed to gynecologic cancer research: The GOG Foundation, Inc’s Scholar Career Development Award and New Investigator Program

HIGHLIGHTS

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PRESS RELEASE

For Immediate Release

FDA Approves the AVMAPKI FAKZYNJA Combination Therapy as the First-Ever Treatment for Adult Patients with KRAS-mutated Recurrent Low-Grade Serous Ovarian Cancer

BOSTON–(BUSINESS WIRE)–May 8, 2025— Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced that the U.S. Food and Drug Administration (FDA) has approved AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who received prior systemic therapy. AVMAPKI FAKZYNJA CO-PACK is the first and only FDA-approved medicine for this disease. This indication is approved under accelerated approval based on the tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. AVMAPKI plus FAKZYNJA is only commercially available in the U.S. as an oral combination co-pack with the two prescription products, known as “AVMAPKI FAKZYNJA CO-PACK.”

“Today’s approval of AVMAPKI FAKZYNJA CO-PACK for patients with KRAS-mutated recurrent low-grade serous ovarian cancer represents not only the first-ever FDA-approved treatment specifically for this rare cancer but also a new day for people living with this disease who have been in desperate need of new treatment options,” said Dan Paterson, president and chief executive officer of Verastem Oncology. “We are very proud to bring two innovative medicines in one combination treatment to the LGSOC community. We thank the researchers, patients, and their families participating in our clinical trials, the patient advocacy community, the FDA, and everyone at Verastem for their dedication and commitment to helping us bring AVMAPKI FAKZYNJA CO-PACK to patients in the U.S.”

The accelerated approval of AVMAPKI FAKZYNJA CO-PACK is based on the Phase 2 RAMP 201 clinical trial, which evaluated the combination of AVMAPKI and FAKZYNJA in adult patients with measurable KRAS-mutated recurrent LGSOC.

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PRESS RELEASE

For Immediate Release

Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer

REDWOOD CITY, Calif.–(BUSINESS WIRE)–Mar. 31, 2025– Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that ROSELLA, the company’s pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer, met its primary endpoint of improved progression-free survival, as assessed by blinded independent central review (PFS-BICR).

In ROSELLA, patients treated with relacorilant in addition to nab-paclitaxel chemotherapy experienced a 30 percent reduction in risk of disease progression compared to patients treated with nab-paclitaxel alone (hazard ratio: 0.70; p-value: 0.008). Their median PFS-BICR was 6.5 months, compared to 5.5 months in patients who received nab-paclitaxel alone. At an interim evaluation of overall survival (OS), patients treated with relacorilant plus nab-paclitaxel had a significant improvement in OS, with a median OS of 16.0 months, compared to 11.5 months for patients receiving nab-paclitaxel alone (hazard ratio: 0.69; p-value: 0.012). Relacorilant was well-tolerated and no new safety signals were observed. As was the case in the company’s Phase 2 trial, safety and tolerability were comparable in the two groups.

Complete results from ROSELLA will be presented at a medical conference this year. Results from Corcept’s Phase 2 trial of relacorilant in patients with platinum-resistant ovarian cancer were published in the Journal of Clinical Oncology in June 2023.

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PRESS RELEASE

For Immediate Release

Sutro Biopharma Announces Strategic Portfolio Review Resulting in the Prioritization of its Next-Generation ADC Pipeline

SOUTH SAN FRANCISCO, Calif., March 13, 2025 – Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), an oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced the completion of a strategic portfolio review resulting in the prioritization of its three wholly-owned preclinical programs in its next-generation ADC pipeline, beginning with its potentially best-in-class exatecan ADC targeting Tissue Factor, STRO-004, expected to enter the clinic in the second half of 2025.

Additionally, the Company announced that it is deprioritizing additional investment into development of luvelta across all indications and is reducing headcount by nearly 50 percent. The Company will continue to explore global out-licensing opportunities for luvelta, as Sutro still believes in its potential to provide significant benefit to patients with unmet need. Further, given Sutro’s significant progress in fully externalizing its cell-free manufacturing to scale, the Company intends to exit its internal GMP manufacturing facility by year-end. As a result of this strategic review and reprioritization, the Company’s cash runway is expected into at least the fourth quarter of 2026, excluding anticipated milestones from existing collaborations.

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PRESS RELEASE

For Immediate Release

FAETH THERAPEUTICS AND THE GOG FOUNDATION, INC. (GOG-F) LAUNCH FIRST PHASE 2 COMBINATION TRIAL FOR SAPANISERTIB-SERABELISIB IN PATIENTS WITH ENDOMETRIAL CANCER

AUSTIN, TX and PHILADELPHIA, PA—March 12, 2025—Faeth Therapeutics (Faeth), a clinical-stage biotechnology company focused on metabolism, and The GOG Foundation, Inc. (GOG-F), 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 malignancies, today announced the first patient has been dosed in its Phase 2 combination trial of PIKTOR, which is FTH-001 (serabelisib) and FTH-003 (sapanisertib) with paclitaxel. The trial is the most advanced of its kind to investigate a novel approach of dual PI3Kɑ-mTORC1/2 inhibition targeting cancer metabolism in patients with endometrial cancer.

The PI3K/AKT/mTOR pathway is the most frequently mutated pathway in cancer and is essential for tumor metabolism. Endometrial cancer has the highest frequency of PI3K pathway mutations of any solid tumor, yet there are no approved therapies addressing this need. FTH-001, a PI3Kɑ inhibitor, and FTH-003, an mTORC 1/2 inhibitor, have both demonstrated potential in multiple previous cancer clinical trials and their combination represents a unique “multi-node” approach to targeting this pathway.

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