Pierre Fabre Laboratories announced that the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the approval of Braftovi (encorafenib) in combination with Mektovi (binimetinib) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with a BRAFV600E mutation. The positive opinion will now be submitted to the European Commission (EC) with a decision on EU marketing authorization (MA) expected later this year.
Eric Ducournau, chief executive officer, Pierre Fabre Laboratories said, “The positive CHMP opinion marks a pivotal step in our commitment to delivering an additional effective targeted treatment option for patients with advanced NSCLC with a BRAFV600E mutation, who at present have limited treatment options. We look forward to the European Commission’s decision to make Braftovi + Mektovi available to non-small cell lung cancer patients in Europe.”
The CHMP positive opinion is supported by data from the global, open-label, multicentre, non-randomised phase II PHAROS trial, which included 98 patients from 56 study centres across 5 countries.
At primary analysis, the primary endpoint of the trial (objective response rate [ORR] determined by independent radiology review [IRR]) was met. The PHAROS trial showed that in patients with advanced NSCLC with a BRAFV600E mutation, Braftovi and Mektovi provided a meaningful clinical benefit with an ORR of 75% in treatment naïve patients (n=59), with 59% of them maintaining their response for at least 12 months. For those patients who had received prior therapy (n=39), the ORR was 46%, with 33% maintaining their response for at least 12 months.
The median progression-free survival (PFS) according to IRR was not estimable (NE) for the treatment naïve group and was 9.3 months (95% CI: 6.2, NE) for the previously treated group. Median overall survival (OS) was NE for either subgroup.
The most common (≥20%) treatment-related adverse events (TRAE) observed in the PHAROS trial were nausea (50%), diarrhea (43%), fatigue (32%) and vomiting (29%). Treatment-related serious AEs occurred in 14% of patients, with the most common being colitis (3%). One grade 5 TRAE of intracranial hemorrhage was reported.
Braftovi + Mektovi are currently approved in Europe for the treatment of adult patients with unresectable or metastatic melanoma with a BRAFV600 mutation. Braftovi in combination with cetuximab is also approved in Europe for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAFV600E mutation who have received prior systemic therapy. On the 12th October 2023, Pierre Fabre Laboratories partner Pfizer, announced the approval of Braftovi + Mektovi by the U.S. food and drug administration (FDA) for the treatment of adult patients with BRAFV600E mutant metastatic NSCLC, as detected by an FDA approved test.
