Lead NEMO Author Shares Excitement With Binimetinib in NRAS-Mutant Melanoma

Excerpt:

“For patients with NRAS-mutant melanoma who progress following treatment with an immunotherapy agent, the MEK inhibitor binimetinib offers a promising option, explains Reinhard Georg Dummer, MD.

“Results of the open-label phase III NEMO trial, which were presented during the 2016 ASCO Annual Meeting,1 most recently demonstrated the agent’s potential. In the study, binimetinib was found to reduce the risk of progression or death by 38% when compared with dacarbazine in this subgroup of patients.

“Additionally, median progression-free survival (PFS) with binimetinib was 2.8 months versus 1.5 months with dacarbazine (HR, 0.62; 95% CI, 0.47-0.80; P <.0001). The objective response rate with binimetinib was 15%, including 1 complete response, compared with 7% for dacarbazine.”

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Binimetinib Improves PFS in NRAS-Mutated Metastatic Melanoma

Excerpt:

“The novel MEK inhibitor binimetinib resulted in improved progression-free survival (PFS) and response rates vs dacarbazine in patients with NRAS-mutated advanced unresectable/metastatic melanoma, according to results of an open-label phase III trial.

“ ‘NRAS mutations are present in approximately 20% of all patients with metastatic melanoma,’ said Reinhard Dummer, MD, of the University Hospital Zurich in Switzerland. ‘It activates the MAPK pathway and by this drives cell proliferation and anti-apoptotic mechanisms.’ Preclinical studies have shown that NRAS-mutant melanoma is sensitive to MEK inhibition, and binimetinib inhibits both MEK1 and MEK2. A phase II study showed clinical activity in NRAS-mutant metastatic melanoma.

“The NEMO trial included 402 patients randomized 2:1 to receive either binimetinib (269 patients) or dacarbazine (133 patients; 19 were not treated and were not evaluated for safety). Patients were either treatment-naive or had progressed on or after immunotherapy. The primary endpoint of the study was PFS. The results were presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting held earlier this month in Chicago (abstract 9500).”

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Array BioPharma Announces Phase 3 Binimetinib Trial Meets Primary Endpoint For NRAS-Mutant Melanoma

“Array BioPharma (Nasdaq: ARRY) today reported top-line results from the ongoing Phase 3 clinical trial of binimetinib in patients with advanced NRAS-mutant melanoma, known as the NEMO trial.  The study met its primary endpoint of improving progression-free survival (PFS) compared with dacarbazine treatment. The median PFS on the binimetinib arm was 2.8 months versus 1.5 months on the dacarbazine arm; hazard ratio (HR) 0.62, [95% CI 0.47-0.80], p < 0.001.”


Binimetinib And Encorafenib Combination Shows Promising Clinical Activity And Potential Differentiated Safety In BRAF-Mutant Melanoma

“Array BioPharma’s (NASDAQ: ARRY) wholly-owned MEK inhibitor, binimetinib, and BRAF inhibitor, encorafenib, were showcased at the 2015 annual meeting of the American Society of Clinical Oncology (ASCO). At the meeting, preliminary data for the combination of binimetinib and encorafenib from a Phase 1b/2 dose escalation and expansion study in patients with BRAF-mutant melanoma who are BRAF inhibitor treatment naive were shared during an oral presentation. Results from the study indicate that binimetinib and encorafenib may be safely combined and show encouraging clinical activity consistent with MEK/BRAF inhibitor expectations in patients with BRAF-mutant melanoma who are BRAF inhibitor treatment naive. In addition, a differentiated safety profile relative to other MEK/BRAF inhibitor combinations is emerging in the dose range currently being used in the Phase 3 COLUMBUS trial.  Array expects updated BRAF melanoma data from the ongoing Phase 2 combination trial (LOGIC-2) of binimetinib and encorafenib followed by the addition of a third targeted agent identified based on genetic testing at the time of progression will be submitted to a scientific conference later this year.  LOGIC-2 utilizes the same dose of binimetinib and encorafenib currently being studied in the COLUMBUS trial.”


ASCO 2014: Highlights for People Dealing with Melanoma


Every year, new cancer treatment insights are shared at the American Society of Clinical Oncology (ASCO) Annual Meeting. Here are some of the most notable recent developments in melanoma treatment, gleaned from researchers’ presentations at ASCO last month: Continue reading…


Two Array-Invented MEK Inhibitors Showcased At ASCO

“Two Array BioPharma-invented MEK inhibitors, binimetinib (MEK162) and selumetinib, were showcased at the 50th annual meeting of the American Society of Clinical Oncology (ASCO).  At the meeting, preliminary data for the combination of binimetinib and CDK4/6 inhibitor LEE011 (discovered by Novartis Institutes for BioMedical Research in collaboration with Astex Pharmaceuticals) from a Phase 1b/2 dose-escalation study conducted by Novartis in NRAS-mutant melanoma indicates the combination demonstrated an acceptable safety profile for most patients with promising preliminary antitumor activity.  Additionally, preliminary data for selumetinib showed favorable clinical activity in pediatric patients with neurofibromatosis type 1 (NF1) and plexiform neurofibromas (PNs).”

Editor’s note: This article discusses a melanoma treatment that combines two durgs: binimetinib (aka MEK162) and selumetinib. A clinical trial recently found that the combo shows promise for melanoma patients whose tumors have mutations in the NRAS gene, as detected by molecular testing. Binimetinib is also being tested as a potential treatment for patients whose tumors have mutations in the BRAF gene.


Binimetinib Continues To Advance In Clinical Development

“Three Phase 3 trials with binimetinib continue to enroll in advanced cancer patients:  NRAS-mutant melanoma (NEMO / NCT01763164), low-grade serous ovarian cancer (MILO / NCT01849874) and BRAF-mutant melanoma (COLUMBUS / NCT01909453).  NRAS-mutant melanoma represents the first potential indication for binimetinib, with a projected regulatory filing from the NRAS-mutant melanoma study estimated to be in 2015.”

Editor’s note: This is a press release from a company that is testing a new potential treatment for melanoma called binimetinib, or “MEK162.” The drug is being tested in clinical trials (learn more about clinical trials). One of the trials is enrolling melanoma patients whose tumors have mutations in the NRAS gene, as detected by molecular testing. Another is enrolling patients with BRAF mutations.