Defactinib

Verastem Oncology completed a rolling NDA submission to the FDA for avutometinib/defactinib as a therapy for recurrent KRAS-mutated LGSOC, with a priority review requested. The regimen showed a 31% overall response rate and a median PFS of 12.9 months, potentially becoming the first FDA-approved treatment for this condition.

Verastem Oncology submitted a New Drug Application to the FDA for avutometinib plus defactinib to treat recurrent KRAS-mutant, low-grade serous ovarian cancer, a rare disease with no current FDA-approved treatments. The combination targets RAF/MEK and FAK pathways, potentially offering a new treatment paradigm. The application includes positive results from the RAMP 201 study, showing a 44% response rate and 22-month median progression-free survival in KRAS-mutant patients.

Verastem Oncology completes NDA submission to FDA for avutometinib and defactinib combination in recurrent KRAS mutant low-grade serous ovarian cancer, with potential approval by mid-2025.

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 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.