Could Adding a TLR9 Agonist Improve Responses in Metastatic Melanoma?

Excerpt:

“A phase I trial found promising activity and good tolerability with the combination of pembrolizumab and a stimulant of Toll-like receptor 9 (TLR9) known as SD-101 in patients with unresectable or metastatic melanoma, particularly in those who had not received prior anti–programmed death 1 (PD-1)/programmed death ligand 1 (PD-L1) therapy.

“PD-1/PD-L1 inhibition has improved outcomes in metastatic melanoma, and studies have indicated that combination therapy can increase immune responses further. “Despite the improvement in response rates with combination immunotherapy, a large unmet need remains,” wrote study authors led by Antoni Ribas, MD, PhD, of the University of California, Los Angeles, Jonsson Comprehensive Cancer Center.”

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Drug Combination Targeting HSP90 and BRAF Is Safe and Effective in Advanced Melanoma

Excerpt:

“Patients with advanced or metastatic melanoma have been able to live longer cancer-free lives because of several new therapies approved over the last decade, such as BRAF and MEK inhibitors. However, despite the success of these targeted agents, most patients eventually develop drug resistance and their cancer regrows. A team of researchers at Moffitt Cancer Center have been working to learn more about how melanoma becomes resistant to BRAF inhibitors in order to develop new treatment strategies. They tested whether a drug targeting heat shock protein 90 (HSP90) combined with the BRAF inhibitor vemurafenib could be a safe and potentially effective strategy to treat patients with melanoma. Their study was published online ahead of print in Clinical Cancer Research.”

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Incyte and Merck Provide Update on Phase 3 Study of Epacadostat in Combination with Keytruda (Pembrolizumab) in Patients with Unresectable or Metastatic Melanoma

Excerpt:

“Incyte Corporation (Nasdaq:INCY) and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that an external Data Monitoring Committee (eDMC) review of the pivotal Phase 3 ECHO-301/KEYNOTE-252 study results evaluating Incyte’s epacadostat in combination with Merck’s KEYTRUDA® in patients with unresectable or metastatic melanoma determined that the study did not meet the primary endpoint of improving progression-free survival in the overall population compared to KEYTRUDA monotherapy.  The study’s second primary endpoint of overall survival also is not expected to reach statistical significance. Based on these results, and at the recommendation of the eDMC, the study will be stopped. The safety profile observed in ECHO-301/KEYNOTE-252 was consistent with that observed in previously reported studies of epacadostat in combination with KEYTRUDA.”

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Research Is Changing the Game for Melanoma Treatment

Excerpt:

“Wilmot Cancer Institute patients with advanced melanoma (stage III) now have more options for treatment, thanks to research co-authored by a University of Rochester Medical Center surgical oncologist and published in The Lancet Oncology.

“The study involved comparing two treatment approaches for high-risk melanoma patients with a BRAF gene mutation in their cancer: standard care, which calls for upfront surgery, or giving a two-drug, targeted therapy regimen before surgery and again afterward. Patients in the latter group had longer disease-free survival in the Phase 2 trial, and after seven months researchers halted the study earlier than expected due to the positive results.”

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Some Melanoma Respond to Immunotherapy Beyond Progression

Excerpt:

“Some patients with unresectable or metastatic melanoma who receive immunotherapy and continue therapy after progression have decreased tumor burden, and survival is improved when the therapy is continued as well, according to a new pooled analysis.

“Since the approval of immune therapies for melanoma, concerns have been raised regarding the adequacy of standard RECIST criteria to identify responses and progression. ‘Patients who receive immunotherapy might develop an atypical response pattern, wherein they initially meet conventional response criteria for progressive disease but later have decreases in tumor burden,’ wrote study authors led by Julia A. Beaver, MD, of the US Food and Drug Administration in Silver Spring, Maryland.”

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Metastatic Melanoma Patients May Benefit From Beta Blockers

Excerpt:

“Beta blockers appear to affect immune cells and improve immune function, and now investigators are reporting that beta blockers may play an important role in boosting immunotherapy in patients with metastatic melanoma. Researchers at Penn State University conducted a retrospective study and found that melanoma patients who received immunotherapy while taking a pan beta blocker lived longer than patients who received immunotherapy alone.”

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Array BioPharma Announces FDA Acceptance For Review Of Binimetinib And Encorafenib New Drug Applications For Patients With Advanced BRAF-mutant Melanoma

Excerpt:

“Array BioPharma (ARRY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Applications (NDAs) to support use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The FDA set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 30, 2018 for both applications. In addition, the FDA informed Array that based on their preliminary review of the applications they have not identified any potential review issues, and that they are not currently planning to hold an advisory committee meeting to discuss these NDAs.  Array completed its NDA submissions at the end of June 2017based on findings from the pivotal Phase 3 COLUMBUS trial.”

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Immunotherapy Combination Safe and 62 Percent Effective in Metastatic Melanoma Patients

Excerpt:

“Immunotherapy is a promising approach in the treatment of metastatic melanoma, an aggressive and deadly form of skin cancer; but for most patients, immunotherapy drugs so far have failed to live up to their promise and provide little or no benefit. In a phase 1b clinical trial with 21 patients, researchers tested the safety and efficacy of combining the immunotherapy drug pembrolizumab with an oncolytic virus called T-VEC. The results suggest that this combination treatment, which had a 62% response rate, may work better than using either therapy on its own. The study appears September 7 in the journal Cell.”

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Study: Common Surgical Treatment for Melanoma Does Not Improve Patients’ Overall Survival

Excerpt:

“Patients who receive the standard surgical treatment for melanoma that has spread to one or more key lymph nodes do not live longer, a major new study shows.

“The study, published today in The New England Journal of Medicine, found that immediately removing and performing biopsies on all lymph nodes located near the original tumor, a procedure called completion lymph node dissection, did not result in increased overall survival rates.”

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