Avutometinib

Verastem Oncology completes NDA submission to FDA for avutometinib plus defactinib as treatment for recurrent KRAS mutant low-grade serous ovarian cancer, aiming for potential first-in-class approval.

FDA approves zolbetuximab plus chemo for CLDN18.2+ gastric or GEJ adenocarcinoma; Gilead to withdraw sacituzumab govitecan indication in urothelial cancer; FDA approves Optune Lua for metastatic NSCLC after platinum-based chemotherapy; Verastem Oncology to submit NDA for avutometinib/defactinib combo in KRAS+ ovarian cancer; lurbinectedin/atezolizumab combo improves survival in ES-SCLC.

A clinical trial showed that a combination of avutometinib and defactinib can shrink tumours in women with low-grade serous ovarian cancer, with 31% seeing tumour reduction and 44% with KRAS mutation experiencing tumour shrinkage. The treatment promises a new standard of care, with lower toxicity and fewer side effects compared to conventional treatments.

Avutometinib and defactinib combo shows 31% ORR and 12.9 months median PFS in recurrent low-grade serous ovarian cancer; 44% ORR in KRAS-mutant, 17% in KRAS wild-type. Median response duration: 31.1 months in KRAS-mutant, 9.2 months in wild-type. Disease control rates: 61% overall, 70% in KRAS-mutant, 50% in wild-type. Verastem Oncology plans FDA NDA submission by October 2024.

Avutometinib with defactinib showed robust responses in recurrent low-grade serous ovarian cancer, with a confirmed overall response rate of 31% and median duration of response of 31.1 months in KRAS-mutated disease. The combination therapy was well-tolerated, with no new safety signals, and is being considered for new drug application submission by Verastem Oncology.

Verastem Oncology initiated a rolling NDA submission to the FDA for avutometinib and defactinib combination therapy for recurrent low-grade serous ovarian cancer (LGSOC). The FDA may consider a broader indication if significant improvement is shown. Final clinical data submission is planned for the second half of 2024, with interim data showing promising response rates.

Verastem Oncology plans to submit an NDA in Oct 2024 for avutometinib and defactinib combo to treat recurrent low-grade serous ovarian cancer with KRAS mutations. Data from the RAMP 201 trial showed a 31% ORR in the overall population and a 44% ORR in KRAS-mutated patients, with a median DOR of 31.1 months. The combo was well-tolerated, with no new safety signals.

Verastem Inc. (VSTM) is developing Avutometinib for low-grade serous ovarian cancer (LGSOC), with a phase II trial (RAMP 201) showing 31% overall response rate. The company started an NDA submission in May 2024 and expects FDA decision in H1 2025. A phase III study (RAMP 301) is ongoing, and Avutometinib is also being tested in NSCLC and pancreatic cancer trials.

Avutometinib and defactinib combo shows 31% overall response rate in recurrent low-grade serous ovarian cancer patients, with 44% in KRAS mutant and 17% in KRAS wild-type. Median progression-free survival is 12.9 months, 22 months in KRAS mutant. Verastem Oncology plans NDA submission in October 2024.

Dr. Hayslip appointed as Verastem Oncology's chief medical officer to lead avutometinib development programs, including the international Phase 3 RAMP 301 trial, and advance pipeline assets.