Three-Drug Regimen Active in BRAF-Mutant Melanoma

Excerpt:

“Triplet therapy for advanced, BRAF V600-mutant melanoma led to objective responses in 73% of a small group of patients enrolled in a phase I trial, according to updated results reported at the 2017 ESMO Annual Congress in Madrid.

“Ongoing follow-up in the trial showed that 11 of 15 patients responded to the combination of pembrolizumab (Keytruda), dabrafenib (Tafinlar), and trametinib (Mekinist). Seven of the 11 responding patients had not progressed after a median follow-up of 20 months. ‘Updated results of the phase I portion of the KEYNOTE-022 trial confirmed previously reported efficacy of this triplet combination,’ said Antoni Ribas, MD, PhD, a professor of medicine, surgery, and molecular and medical pharmacology at the University of California at Los Angeles. ‘The results demonstrated durability of responses. No late or unexpected toxicities occurred with longer follow-up. The randomized phase II portion of KEYNOTE-022 is ongoing.’ ”

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Neoadjuvant Dabrafenib/Trametinib Leads to High pCR Rates in Bulky Resectable Melanoma, But Recurrences Are Common

Excerpt:

“Phase II results demonstrated that nearly half of patients with resectable stage IIIB/C BRAF V600-mutant melanoma achieved pathologic complete response (pCR) with neoadjuvant combination therapy consisting of dabrafenib (Tafinlar) and trametinib (Mekinist). Additionally, no patients experienced disease progression during the neoadjuvant treatment, said Alexander M. Menzies, MD, who presented the data at the 2017 ESMO Congress in Madrid.

” ‘Nearly 50% of our patients had a complete eradication of their melanoma at the time of surgery. Fifty percent had some remaining melanoma in the surgical specimen, but every patient had some degree of tumor shrinkage on therapy,’ said Menzies, a medical oncologist and senior research fellow at Melanoma Institute Australia in Sydney, Australia. ‘These are patients who otherwise would just have surgery and then have observation. And, these are patients who are at very high risk, probably the highest risk of recurrence without further therapy.’ ”

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Novartis Posts a Win, Roche a Flop in Skin Cancer Trials

Excerpt:

“Swiss drugmaker Novartis notched a trial win for its drug cocktail against skin cancer on Monday, while a rival treatment from Roche with slipping sales failed in a separate study with a similar patient group.

“All the medicines were tested in melanoma patients who had undergone surgery to cut out tumors and had a genetic mutation called BRAF, making them likely to respond to the targeted cancer pills. Patients with BRAF mutations constitute around half of the melanoma population.”

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Targeted BRAF/MEK Inhibitor Combination Achieves Long-Term Survival in Melanoma

Excerpt:

“More than one-fourth of patients with advanced BRAF V600-mutant melanoma remained alive at 5 years after treatment with the combination of dabrafenib (Tafinlar) and trametinib (Mekinist), long-term follow-up from a randomized trial showed.

“In the subgroup of patients with normal baseline lactate dehydrogenase (LDH) and fewer than 3 organ sites with metastases, half remained at alive at 5 years. No new safety signals emerged during long-term follow-up, as reported at the 2017 ASCO Annual Meeting in Chicago.”

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FDA Approves Tafinlar Plus Mekinist for BRAF V600E–Mutant Non–Small Cell Lung Cancer

Excerpt:

“The FDA approved use of dabrafenib in combination with trametinib for treatment of patients with metastatic non–small cell lung cancer whose tumors harbor BRAF V600E mutations, according to the agents’ manufacturer.

“The combination of dabrafenib (Tafinlar, Novartis) — a BRAF inhibitor — and trametinib (Mekinist, Novartis), a MEK1/2 inhibitor — is the first targeted treatment approved in the United States specifically for patients with BRAF V600E–positive metastatic NSCLC.”

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Super Patient: Peter Fortenbaugh Faces the Uncertainty of Pioneering Melanoma Treatment


In spring of 2014, Peter Fortenbaugh noticed what appeared to be a tick that had bitten his lower calf. “It turned out not to be a tick, but it didn’t really go away,” he says.

The spot began to grow and bulge, and in October, Peter showed it to his primary care doctor, who referred him to a dermatologist to remove it. At the time, Peter recalls, it did not occur to him that the growth could be serious.

“I was actually very concerned about skin cancer because I spent a lot of time out in the sun sailing,” Peter says. “I put on a tremendous amount of sunscreen and protection, but never on my legs…I never connected the dots.”

However, a biopsy of the growth came back positive for melanoma. Peter, who lives in Palo Alto, California, with his wife and three children, immediately reached out to several doctors in the San Francisco Bay Area, and all had the same advice: “Take it out, take a biopsy.” Continue reading…


Melanoma: New Drugs and New Challenges (Part 1 of 2)


New targeted and immunotherapy drugs have changed the diagnosis of metastatic melanoma from a death sentence into a disease that can potentially be managed and even cured. Nevertheless, these new drugs do not work in all patients, or they may stop working after a transient response. This post (part one of two) will describe ongoing efforts to find drug combinations with higher efficacy than single drugs and decipher the mechanisms underlying drug resistance. Continue reading…


Lung Cancer Highlights from ASCO 2016


This year, the Annual Meeting of the American Society of Clinical Oncology (ASCO) did not produce any truly groundbreaking revelations about new treatments for lung cancer. However, researchers did report quite a few positive findings, and some disappointing ones. I have summarized some of the more prominent presentations below. Continue reading…


3-Year Follow-Up Data for Dabrafenib/Trametinib Confirm Results of Combo in Melanoma

Excerpt:

“Three-year follow-up data from the phase III COMBI-d study was presented at the 2016 ASCO Annual Meeting, revealing impressive overall survival (OS) and progression-free survival (PFS) data for the dabrafenib (Tafinlar) and trametinib (Mekinist) combination therapy for patients with BRAF-mutant metastatic melanoma.

“At the February 15, 2016 data cutoff for the 3-year analysis, 58% of patients remained on therapy. The 3-year PFS rate with the combination was 22% versus 12% with single-agent dabrafenib. The 3-year OS rate was 44% with dabrafenib plus trametinib compared with 32% with dabrafenib alone.

” ‘This is the longest OS follow-up among randomized phase III trials evaluating a BRAF plus MEK inhibitor in patients with BRAF-mutant metastatic melanoma,’ said lead investigator Keith T. Flaherty, MD, Massachusetts General Hospital Cancer Center and Professor of Medicine, Harvard Medical School. ‘With additional follow-up, and now 3-year maturity, dabrafenib plus trametinib continued to show significant benefit over dabrafenib monotherapy, despite crossover.’ ”

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