**Professional Translation:** **Bytavy® in Combination with Mektovi® Approved in China for Precision Targeting of BRAF V600E-Mutant NSCLC** **Alternative (more concise):** **Bytavy® + Mektovi® Approved in China for BRAF V600E-Mutant NSCLC**

Castres, FranceJune 16, 2026 /PRNewswire/ — Pierre Fabre Group announced on June 15 that the combination therapy of Braftovi® (encorafenib) and Mektovi® (binimetinib) has been officially approved by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with BRAF^V600E mutation-positive metastatic non-small cell lung cancer (NSCLC).

Lung cancer is the leading cause of cancer-related deaths in China and represents a significant public health burden. The country reports nearly 733,300 lung cancer deaths annually, with over 1,060,500 new cases each year.^[1] This approval in China is primarily based on data from the global pivotal Phase II PHAROS study (which facilitated the drug’s approval in the European Union and the United States)^[2] and the local Phase II OCEAN II study conducted in China.^[3] Both studies confirmed that the combination therapy provides significant clinical benefits, with consistent efficacy observed in both global and Chinese patient populations.

Results from the PHAROS trial showed that at the primary analysis time point (cutoff date: September 22, 2022), the primary endpoint of objective response rate (ORR), as determined by independent radiological review (IRR), met the prespecified target. In treatment-naïve patients (n=59), the ORR was 75% (95% CI: 62-85), while in previously treated patients (n=39), the ORR was 46% (95% CI: 30-63).^[1] 

The pivotal Chinese registration study, OCEAN II, demonstrated efficacy and safety results consistent with those of PHAROS. Núria Perez-Cullell, Head of the Medical and Consumer Healthcare Division, stated: “This new combination therapy reaching a broader patient population further underscores Pierre Fabre Group’s ongoing commitment to areas of unmet medical need, such as lung cancer. Currently, targeted treatment options for BRAF^V600E mutation-positive NSCLC remain limited. This subtype accounts for approximately 2.7% of all NSCLC cases in China.^[4] Having access to a new treatment option with proven clinically meaningful and durable efficacy represents a significant advancement.”

Marie-Andrée GAMACHE, Chief Executive Officer of Pierre Fabre Pharmaceuticals, added: “The approval of the Braftovi^® and Mektovi^® combination therapy in China is an important milestone. We are one step closer to bringing this treatment option to Chinese patients with BRAF^V600E mutation-positive metastatic NSCLC. We are working closely with Chinese regulatory authorities and healthcare professionals to make this therapy available to eligible patients as quickly as possible.”  

“Building on close collaboration with health regulatory authorities, we are bringing this treatment to patients in need in China. This reflects our unwavering commitment to continuously improving the quality of life for Chinese patients by providing treatment options with clinically meaningful value in areas of significant unmet need,” said Huang Tianwei, President of Pierre Fabre Pharmaceuticals China.

About PHAROS

The PHAROS trial was sponsored by Pfizer and conducted with support from Pierre Fabre.

About OCEAN II

OCEAN II (NCT05195632) is a Phase II, multicenter, single-arm study conducted in China, comprising a safety lead-in phase and an expansion phase. It aims to evaluate the efficacy, safety, and pharmacokinetics of Braftovi® (encorafenib) in combination with Mektovi® (binimetinib) in Chinese adult subjects with unresectable Stage IV BRAF^V600E mutation-positive NSCLC. Enrolled subjects were those who had not previously received BRAF and MEK inhibitors, and who were either treatment-naïve in the metastatic setting or had received only one prior line of therapy. The primary endpoints are dose-limiting toxicities (DLTs) during the first 28-day cycle (SLI) and the confirmed objective response rate (cORR) assessed by independent central review (ICR). Secondary endpoints include disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety. Pierre Fabre Group is the sole sponsor of this study.

About BRAF^V600E Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the leading cause of cancer-related deaths, causing over 1.8 million deaths globally each year.^[5] Worldwide, lung cancer accounts for 12.4% of all cancers, with over 2.4 million new cases annually. Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases.^[6]

Precision medicine has significantly advanced treatment for NSCLC patients harboring genetic alterations, such as the BRAF^V600E mutation. These genetic changes can be identified through biomarker testing.^[7,8]

In China, among over 175,000 NSCLC patients, the detection rate of BRAF (B-Raf proto-oncogene) mutations is 3.6%, with a detected prevalence of BRAF^V600E mutations at 0.9%.^[9]

Currently, it is estimated that up to 69% of patients with advanced NSCLC harbor druggable mutations across multiple genes.^[10]

BRAF^V600E mutations account for approximately 1%–2% of NSCLC cases.^[11] This mutation drives tumor cell growth and proliferation by aberrantly activating the MAP kinase (MAPK) signaling pathway. Studies have shown that simultaneously inhibiting BRAF and the downstream MEK pathway significantly improves patient response rates compared to BRAF inhibitor monotherapy.^[12]

In recent years, advances in targeted therapy and the increased availability of biomarker testing have significantly reduced mortality rates in the NSCLC population.^[13]

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