Avmapki Fakzynja (avutometinib/defactinib) / Verastem - LARVOL DELTA

Verastem Oncology Announces Publication in Gynecologic Oncology of Two-Year Median Follow-Up Data from RAMP 201 Study of AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) in Recurrent Low-Grade Serous Ovarian Cancer (Businesswire) - "In the updated analysis, with ongoing patients presenting a median follow-up of 24.9 months, efficacy measures, including median duration of response (mDoR) and median progression free survival (mPFS), and safety, are consistent with the primary analysis, which was conducted more than 13 months prior...Fifty percent of patients with KRAS-mutated and 30% with KRAS wild-type LGSOC remained on therapy for more than one year. Importantly, the median DoR for patients with KRAS wild-type LGSOC has increased from 9.2 to 12 months. Adverse events (AEs) were consistent with the primary analysis with no new safety signals observed, and a 12% discontinuation rate due to AEs."

P2 data • Low Grade Serous Ovarian Cancer

Verastem Oncology Reports Second Quarter 2026 Financial Results (Businesswire) - "AVMAPKI FAKZYNJA CO-PACK generated net product revenue of $25.1 million for the second quarter of 2026."

Sales • Low Grade Serous Ovarian Cancer

AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets):…Expected Key Milestones (Businesswire) - "(i) Report a topline readout of the primary endpoint in the RAMP 301 trial in mid-2027; (ii) Continue to pursue regulatory paths for potential expansion of recurrent LGSOC into Europe and Japan."

European regulatory • Japanese regulatory • P3 data: top line • Low Grade Serous Ovarian Cancer

In July, updated data from the RAMP 201 Japan study were presented at the Annual Meeting of the Japanese Society of Gynecologic Oncology (JSGO) held July 17-19, 2026, in Sapporo, Japan (Businesswire) - "As of May 29, 2026, 16 efficacy-evaluable patients with recurrent low-grade serous ovarian cancer (LGSOC) had received avutometinib plus defactinib, with a median follow up of 12.4 months. The combination achieved a 44% overall response rate and a 94% disease control rate across all patients. Response rates were 71% in patients with KRAS-mutated tumors and 22% in those with KRAS wild-type tumors, with disease control rates of 100% and 89%, respectively. Overall, 94% of patients experienced tumor shrinkage, and 11 of 16 patients remained on treatment at the data cutoff."

P2 data • Low Grade Serous Ovarian Cancer

AVMAPKI FAKZYNJA CO-PACK…: Expected Key Milestones (Businesswire) - "(i) Report a topline readout of the primary endpoint in the RAMP 301 trial in mid-2027; (ii) Continue to pursue regulatory paths for potential expansion into Europe and Japan."

European regulatory • Japanese regulatory • P3 data: top line • Low Grade Serous Ovarian Cancer

AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) U.S. Commercial Performance (Businesswire) - "AVMAPKI FAKZYNJA CO-PACK generated net product revenue of $18.7 million for the first quarter of 2026."

Sales • Low Grade Serous Ovarian Cancer

Verastem Oncology Launches HCP and Patient Reimagine Campaign to Increase Awareness of AVMAPKI FAKZYNJA CO-PACK for KRAS-Mutated Recurrent Low-Grade Serous Ovarian Cancer (Businesswire) - "For HCPs, the campaign encourages re-evaluation of treatment approaches in the context of a treatment specifically approved by the FDA for KRAS-mutated recurrent LGSOC. For patients, it reflects a desire not only to manage their condition, but to envision a future shaped by progress and meaningful life milestones."

Commercial • Low Grade Serous Ovarian Cancer

Verastem Oncology Announces Two-Year Median Follow-Up Data on AVMAPKI FAKZYNJA Combination Therapy (avutometinib capsules; defactinib tablets) in Recurrent Low-Grade Serous Ovarian Cancer at the SGO 2026 Annual Meeting on Women’s Cancers (Businesswire) - "Fifty percent of patients with KRAS-mutated and 30 percent with KRAS wild-type LGSOC remained on therapy for more than one year. Adverse events (AEs) were consistent with the primary analysis with no new safety signals observed, and a 12 percent discontinuation rate due to adverse events."

P2 data • Low Grade Serous Ovarian Cancer

Exposure-Response Analysis for Avutometinib in Combination with Defactinib in LGSOC (Businesswire) - "Efficacy analyses included patients with LGSOC (N=158) from the FRAME and RAMP 201 studies, while safety analyses included a broader population (N=303) from the FRAME, RAMP 201, and RAMP 202 studies. All efficacy endpoints, including overall response rates, duration of response, and best target lesion response, suggest the best therapeutic effect is achieved with the FDA approved dose of avutometinib 3.2 mg twice weekly plus defactinib 200 mg twice daily. While a lower avutometinib dose may mitigate treatment emergent adverse events (TEAEs) (the most frequent being grade ≥2 skin disorders (39.9%; n=121), followed by grade ≥2 gastrointestinal toxicity (34.0%; n=103), grade ≥2 liver function tests (25.1%; n=76), and grade ≥3 creatine phosphokinase elevation (14.5%; n=44)), it may also compromise the efficacy."

Clinical data • Low Grade Serous Ovarian Cancer

AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) U.S. Launch (Businesswire) - "AVMAPKI FAKZYNJA CO-PACK generated net product revenues of $17.5 million for the fourth quarter of 2025 and $30.9 million for the full year 2025, following accelerated U.S. Food and Drug Administration (FDA) approval in May 2025..."

Sales • Low Grade Serous Ovarian Cancer