The European Medicines Agency approved Pierre Fabre Laboratories' marketing authorization application for the combination BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib) for patients with advanced non-small cell lung cancer (NSCLC) with BRAFV600 mutati

Pierre Fabre Laboratories announced today that the European Medicines Agency (EMA) has approved the marketing authorization application for BRAFTOVI ® (encorafenib) + MEKTOVI ® (binimetinib) for the treatment of adult patients with advanced non-small cell Lung cancer (NSCLC) with BRAF V600 mutation who are either treatment-naïve or have received prior treatment.

The application is based on the results of the PHAROS pivotal study, 1 which, after independent review, showed an objective response rate (ORR) of 75% in treatment-naïve patients, with 59% of patients responding for at least 12 months, and 46% in patients with Pretreatment. 1

“Lung cancer is the leading cause of cancer death worldwide, 2 and there are currently few effective targeted treatment options for patients with BRAF V600 -mutant advanced NSCLC. With our strategic focus on lung cancer and precision medicine in oncology, this application is the next step in achieving clinically meaningful change for oncology patient populations with high unmet need," said Eric Ducournau, Chief Executive Officer of Pierre Fabre Laboratories.

The phase 2 PHAROS 1 study showed that a daily dose of 450 mg BRAFTOVI ® and two daily doses of 45 mg MEKTOVI ® 1 provided a significant clinical benefit for these patients with an ORR of 75% (95% CI: 62, 85). treatment-naïve patients (n=59), with 59% of them responding for at least 12 months. In patients who had received prior therapy (n=39), the ORR was 46% (95% CI: 30, 63), with 33% responding for at least 12 months. Median progression-free survival (PFS) was not reached at the time of data cut-off for the treatment-naïve group (95% CI: 15.7, NE) and 9.3 months (95% CI: 6.2, NE) for the pretreatment group . Median overall survival (OS) was not reached for both subgroups at the time of data cut-off. The most common treatment-related adverse reactions observed in the PHAROS study were nausea (50%), diarrhea (43%), fatigue (32%) and vomiting (29%).

These results were published simultaneously in the Journal of Clinical Oncology and presented at the American Society of Clinical Oncology (ASCO) meeting on June 4, 2023. 1 

BRAFTOVI ® + MEKTOVI ® are currently approved in Europe for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. 3,4 BRAFTOVI ® in combination with cetuximab is also approved in Europe for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600 mutation who have previously received systemic therapy. 3

About PHAROS

PHAROS is an ongoing, open-label, multicenter, non-randomized Phase 2 study to determine the efficacy and safety of BRAFTOVI ® + MEKTOVI ® in 98 patients with metastatic NSCLC with BRAF V600 mutation. The mutations were identified by next generation sequencing (NGS) or by polymerase chain reaction testing performed at the patient's local laboratory. The primary endpoint is confirmed ORR according to RECIST v1.1 by independent radiology review (IRR); secondary objectives include additional efficacy endpoints including DoR, PFS and OS, and safety. The study will be conducted at 56 locations across Europe in: Italy, Netherlands, South Korea, Spain and the USA .

The PHAROS study is sponsored by Pfizer Inc. and conducted with support from Pierre Fabre Laboratories.

About advanced non-small cell lung cancer (NSCLC) with BRAF mutation

Lung cancer is the second most common cancer and the leading cause of cancer-related deaths worldwide. 2 NSCLC accounts for approximately 80-85% of all lung cancer cases. 5

Certain lung cancers are caused by acquired genetic abnormalities, such as a BRAF mutation. Using biomarkers to identify a person's specific tumor type can make treatment more personalized and effective, as the molecular makeup of a person's cancer often determines how they respond to different therapies.

BRAF mutations occur in approximately 3-5% of NSCLC cases. 1 They stimulate the growth and spread of tumor cells by altering the MAP kinase (MAPK) signaling pathway. Targeting components of this signaling pathway could potentially inhibit uncontrolled tumor growth and spread caused by BRAF mutations. 1.6

Precision medicine is increasingly being developed for NSCLC patients with genetic alterations such as BRAF mutations that can be detected using biomarker tests. 7,8 Advances in targeted therapy and broader use of biomarker testing have led to significant improvements in NSCLC mortality at the population level in recent years. 9

About BRAFTOVI ® + MEKTOVI ® 

BRAFTOVI ® (encorafenib) is an oral small molecule BRAF kinase inhibitor and MEKTOVI ® (binimetinib) is an oral molecular MEK inhibitor, both of which target key proteins in the MAPK signaling pathway (RAS-RAF-MEK-ERK). aim. Uncontrolled activation of this pathway has been demonstrated in many types of cancer, including melanoma, CRC and NSCLC. 1 

In 2018, the European Commission (EC) approved BRAFTOVI ® + MEKTOVI ® for adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. The approval was based on the results of the randomized, active-controlled, open-label, multicenter phase 3 COLUMBUS study.

In 2020, BRAFTOVI ® in combination with cetuximab was approved by the European Commission for the treatment of adults with metastatic colorectal cancer with a BRAF V600 mutation. The approval was based on the results of the randomized, active-controlled, open-label, multicenter phase 3 BEACON CRC study.

Pfizer has exclusive rights to commercialize BRAFTOVI ® and MEKTOVI ® in the United States , Canada and all countries in Latin America, Africa and the Middle East. Ono Pharmaceutical Co., Ltd. has exclusive rights to market both products in Japan and South Korea, Medison has exclusive rights in Israel , and Pierre Fabre Laboratories has exclusive rights in all other countries, including Europe and Asia-Pacific.

Full product and safety information for the use of BRAFTOVI ® and MEKTOVI ® is contained in the Summary of Product Characteristics (SmPC) published in the European Public Assessment Report (EPAR)

About Pierre Fabre Laboratories

Pierre Fabre Laboratories is a French medical and beauty care company with over 40 years of experience in innovation, development, manufacturing and marketing in the oncology sector. The company dedicated approximately 80% of its R&D spending to oncology in 2022 and recently made targeted therapies its top R&D priority. Its current commercial portfolio in oncology includes colorectal, breast and lung cancer, melanoma, hematology and precancerous skin diseases such as actinic keratosis. 

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