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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Melanoma Mutation Likes Fat for Fuel

Excerpt:

“Cancer cells love glucose, the simple sugar the body uses for energy, so a high-fat, low-carb diet should starve them, right?

“Not so fast. Research in mice suggests that melanomas and other cancers driven by a particular mutation (BRAF V600E) will grow faster in response to a high-fat diet. In addition, lipid-lowering agents such as statins curb these cancers’ growth, even in the context of a more normal diet.”

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Dabrafenib/Trametinib Combo Highly Effective in BRAF-Mutant NSCLC

Excerpt:

“The combination of dabrafenib (Tafinlar) and trametinib (Mekinist) was highly effective as a treatment for patients with BRAF V600E-mutant non–small cell lung cancer (NSCLC), according to lead investigator David Planchard MD, PhD, who presented the phase II data at the 2016 ASCO Annual Meeting.1 Findings from the study were also concurrently published in Lancet Oncology.2

“The investigator assessed objective response rate (ORR) with the combination was 63% (95% CI, 49-75), which lasted for a median duration of 9.0 months (95% CI, 6.9-18.3). When adding those with stable disease for ≥12 weeks, the overall disease control rate was 79% (95% CI, 66-89). The median progression-free survival (PFS) was 9.7 months (95% CI, 6.9-19.6).

“In addition to the combination cohort, the study also included a single-agent arm that included 78 previously treated patients with metastatic BRAF V600E–mutant NSCLC. In this cohort, the ORR with single-agent dabrafenib was 33% and the median PFS was 5.5 month. Findings from both cohorts of the study have led to breakthrough therapy designations from the FDA for dabrafenib as a single agent and in combination with trametinib.”

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Dabrafenib Active in BRAF-Mutant Metastatic NSCLC

Excerpt:

“Planchard et al found that the BRAF kinase inhibitor dabrafenib (Tafinlar) produced responses in previously treated and untreated patients with BRAF-mutant metastatic non–small cell lung cancer (NSCLC), according to a phase II trial reported in The Lancet Oncology. Activating BRAF V600E mutations are found in approximately 1% to 2% of lung adenocarcinomas.”

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New RAF-targeted Therapeutic Shows Early Promise Against Tumors With BRAF and RAS Mutations

Excerpt:

“The new investigational anticancer therapeutic BGB-283, which targets the RAF family of proteins, was safe, tolerable, and showed signs of clinical activity in patients who had a range of types of cancer with mutations in BRAF, KRAS, and NRAS, according to results from a phase I clinical trial presented here at the AACR Annual Meeting 2016, April 16-20.

“ ‘BRAF gene mutations fuel cancer cell proliferation and survival in a number of types of cancer, including melanoma, and thyroid and colorectal cancers,’ said Jayesh Desai, FRACP, a medical oncologist at The Royal Melbourne Hospital in Melbourne, Australia. ‘In melanoma, the BRAF V600E mutation predominates, and specific inhibitors of the BRAF V600E mutant protein have been approved for treating patients with melanoma with BRAF V600E gene mutations.’ ”

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Vemurafenib/Cobimetinib Combo for Melanoma Approved by FDA

“The FDA has approved a combination of vemurafenib (Zelboraf) and cobimetinib (Cotellic) to treat patients with metastatic or unresectable BRAF V600E/K mutation-positive melanoma. The approval was based on based on an extension in progression-free survival (PFS) in the phase III coBRIM study.

“In the data submitted to the FDA, the median PFS with the combination was 12.3 versus 7.2 months with vemurafenib plus placebo (HR, 0.58; 95% CI, 0.46-0.72). PFS was the primary endpoint of the study with secondary outcome measures including overall survival (OS), objective response rate (ORR), duration of response, and safety.”


Novartis Presents New Data at ASCO for Zykadia® and Combination of Tafinlar® and Mekinist® in Certain NSCLC Patients with Unmet Needs

“Novartis today announced new data from two Phase II studies of Zykadia® (ceritinib), as well as one Phase II study of Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) in certain patients with non-small cell lung cancer (NSCLC). Data from these studies were presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

“The results of the Zykadia studies – ASCEND-2 and ASCEND-3 – reinforce the efficacy of the medicine in patients with anaplastic lymphoma kinase-positive (ALK+) NSCLC who had received previous treatment with an ALK inhibitor and in those receiving an ALK-targeted therapy for the first time. Overall response rates (ORR) seen in these trials were 38.6% and 63.7%, respectively, based upon investigator assessment. Comparable ORR results were observed in patients with ALK+ NSCLC who entered the studies with brain metastases (33% and 58%, respectively)[1],[2].

“Separately, the study of dabrafenib in combination with trametinib in patients with metastatic BRAF V600E-mutation positive NSCLC who had failed at least one round of chemotherapy demonstrated an ORR of 63% in this population[3].”


Good Results for Tafinlar in BRAF V600E Metastatic Melanoma

The gist: An ongoing clinical trial has shown good results for certain metastatic melanoma patients treated with the drug dabrafenib (Tafinlar). Patients in the trial have tumors with “BRAF V600E” mutations. The researchers report that 45% of patients treated with Tafinlar are still alive at two years.

“GSK today announced updated results for Tafinlar® (dabrafenib) from a planned analysis of the phase III BREAK-3 study in 250 patients with BRAF V600E mutant metastatic melanoma. These results, which include new survival data, showed 45 per cent of patients treated with dabrafenib were still alive at two years.1 The data were presented at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid.

“Analysis of the study’s primary endpoint, progression free survival (PFS), was reported in 2012.2 Today’s results relate to a secondary endpoint from this study, with a final analysis of the overall survival (OS) endpoint expected in 2016.

“45 per cent of patients treated with dabrafenib only, were alive at two years compared to 32 per cent of patients who began treatment with dacarbazine (DTIC).  59 per cent of patients on DTIC treatment whose disease progressed subsequently received dabrafenib treatment and are included in the DTIC control arm results. While allowing this treatment cross over means patients in the control arm get the potential benefit of an active experimental drug, this can impact the comparative study findings as patients who received both medicines are included in the DTIC arm results. At the planned two-year follow up, the study showed a median OS of 20.0 months for the dabrafenib arm (95% CI 16.8-24.4) compared to 15.6 months for the DTIC arm (95% CI 12.7-21.2) [hazard ratio (HR) 0.77 (95% CI 0.52-1.13) – not statistically significant].

“ ‘We are encouraged by the 45 per cent survival rate with dabrafenib at two years,’ said Dr. Paolo Paoletti, President of Oncology, GSK. ‘Treatments for melanoma have come a long way in recent years and we’re now seeing the benefits precision medicines can bring to the right patients.’ ”


Drug Combo Cuts Death by One-Third in Metastatic Melanoma with BRAF V600E or V600K Mutations

The gist: Certain metastatic melanoma patients who have not yet been treated may do better if they take the drugs dabrafenib and trametinib than if they take vemurafenib. This was true for patients who had BRAF V600E or V600K mutations in their tumors. The patients participated in a clinical trial to compare the two treatment approaches.

“Patients with previously untreated BRAF V600E or V600K metastatic melanoma had a significant improvement in overall survival when treated with a combination of a BRAF inhibitor and a MEK inhibitor compared with treatment with a BRAF inhibitor alone, according to the results of a study published in the January 1 issue of the New England Journal of Medicine.

“In fact, patients treated with dabrafenib and trametinib had a 31% relative risk reduction for death compared with patients assigned monotherapy with the BRAF inhibitor vemurafenib, with no significant increase in toxicity.

“ ‘Together with the previously reported phase II and phase III trials of dabrafenib plus trametinib, as compared with dabrafenib monotherapy, these data provide clear evidence for the benefit of this combination therapy over BRAF monotherapy in prolonging survival,’ wrote study author Caroline Robert, MD, PhD, Gustave Roussy and INSERM Unité 981, Villejuif-Paris Sud, and colleagues.”