Pierre Fabre Laboratories announced that the European Commission (EC) has approved Braftovitovi (encorafenib) in combination with Mektovi (binimetinib) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with a BraftoviV600E mutation. The approval is based on the results from the Phase II Pharos trial, a global, open-label, multicentre, non-randomised trial to determine the efficacy and safety of Braftovitovi + Mektovi in treatment-naïve and previously treated patients with BraftoviV600E mutant metastatic NSCLC.
“We are pleased to be able to extend the treatment of Braftovitovi (encorafenib) in combination with Mektovi (binimetinib) to adult patients with advanced NSCLC with a BraftoviV600E mutation in Europe” said Eric Ducournau, chief executive officer of Pierre Fabre Laboratories. “There are currently limited targeted treatment options for BraftoviV600E mutant NSCLC patients, so this approval is a significant milestone as Braftovitovi + Mektovi will give patients the option of an additional effective targeted therapy.”
The EC decision, following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) issued on 25 July, is based on the results from the Phase II Pharos trial.1-3 At primary analysis (cut-off date: September 22, 2022), the primary endpoint of the trial (objective response rate [ORR] determined by independent radiology review [IRR]) was met. In the treatment-naïve population (n=59), the ORR was 75% (95% CI: 62, 85), including 15% complete responses (CRs) and 59% partial responses (PRs).1-3 Updated results with an additional 10-month follow-up showed that 64% of patients maintained a response for at least 12 months, with a median duration of response (mDOR) per IRR of 40 months (95% CI: 23.1, not estimable [NE]).
For those patients who had received prior therapy (n=39), the ORR by IRR was 46% (95% CI: 30, 63), including 10% CRs and 36% PRs at primary analysis.1 Updated results with an additional 10-month follow-up showed that 44% of patients maintained a response for at least 12 months with a mDOR of 16.7 months (95% CI: 7.4, NE).
The most common treatment-related adverse events (TRAEs ≥20%) were nausea (50%), diarrhoea (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 haemorrhage was reported.
“The EC approval highlights our ongoing commitment to bring meaningful change to patients with diseases such as lung cancer where there is a high unmet need,” said Núria Perez-Cullell, head of medical, patient, and consumer affairs, Pierre Fabre Laboratories. “Through our longstanding partnership with Pfizer, we have been able to utilize our capabilities and experience to deliver this innovative treatment combination for patients with BraftoviV600E mutant advanced NSCLC. We remain committed to harnessing the full potential of our clinical development programme so that we can continue to bring promising targeted oncology compounds to patients in Europe.”
On 12 October 2023, Pierre Fabre’s partner Pfizer announced the approval of Braftovitovi + Mektovi by the US Food and Drug Administration (FDA) for the treatment of adult patients with BraftoviV600E mutant metastatic NSCLC, as detected by an FDA approved test.4 Braftovitovi + Mektovi are currently approved in Europe and other countries for the treatment of adult patients with unresectable or metastatic melanoma with a BraftoviV600 mutation.5,6 Braftovitovi , in combination with cetuximab, is also approved in Europe and other countries for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BraftoviV600E mutation who have received prior systemic therapy.
