Approval of Braftovi With Mektovi Adds to Targeted Options for Metastatic NSCLC


Dr. Gene G. Finley of Drexel University of College of Medicine and AHN Cancer Institute, Allegheny Clinic Medical Oncology, explains why the approval of Braftovi and Mektovi “It's an important improvement in our armamentarium.”

FDA approval: What you need to know

The FDA approved Braftovi plus Mektovi for metastatic lung cancer, offering this patient population another targeted treatment option.

When the Food and Drug Administration (FDA) approved Braftovi (encorafenib) with Mektovi (binimetinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, it was the latest development for the use of targeted therapies to treat lung cancer, one doctor explained to CURE®.

“It’s just one more in a series of approvals of targeted therapies in lung cancer, which is a story that dates back now for about 15 years (which) is when this originally started,” Dr. Gene G. Finley, assistant professor at Drexel University of College of Medicine and medical oncologist at AHN Cancer Institute, Allegheny Clinic Medical Oncology, said.

“It’s an important improvement in our armamentarium. But we have a bunch of first line approvals in lung cancer for this concept of targeted therapy,” Finley noted. “Traditionally we’d use chemotherapy to treat lung cancer. And then, some of these newer drugs had come on, and particularly in 2005, (which) was the first approval of a targeted therapy in lung cancer, with the approval of an EGFR drug called (Iressa, gefitinib).

“So, this is just building on this whole theme of trying to find targetable (genetic) mutations for patients which you can apply for (treatment with) first line therapy because, in the vast majority of these situations, the (targeted therapy) pill works better than the chemo or the chemo and immunotherapy. And that's why we’ve been searching for these, aside from (targeted therapies having) fewer side effects in general and more convenience for the patient.”

In its approval announcement, the FDA reported that the most common side effects of Braftovi and Mektovi observed in at least 25% of patients included fatigue, nausea, diarrhea, musculoskeletal pain, vomiting, abdominal pain, visual impairment, constipation, dyspnea, rash and cough.

The combination of BRAF inhibitor Braftovi and MEK inhibitor Mektovi was previously approved in 2018 for the treatment of adult patients with BRAF-mutant unresectable or metastatic melanoma and, when combined with the EGFR inhibitor Erbitux (cetuximab), for the treatment of patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) after one to two prior lines of treatment in a metastatic setting.

The most recent approval was based off the phase 2, 98-patient PHAROS trial, results of which, published in the Journal of Clinical Oncology, stated that “for patients with treatment-naïve and previously treated BRAF V600E-mutant metastatic NSCLC, (Braftovi) plus (Mektovi) showed a meaningful clinical benefit with a safety profile consistent with that observed in the approved indication in melanoma.”

Braftovi manufacturer Pfizer explained in the news release that the drug “is an oral small molecule BRAF kinase inhibitor and Mektovi is an oral small molecule MEK inhibitor which target key proteins in the MAPK signaling pathway (RAS-RAF-MEK-ERK),” noting that “inappropriate activation of this pathway has been shown to occur in many cancers, including melanoma, (colorectal cancer) and NSCLC.”

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