ASCO15 EXCLUSIVE: Cancer Drug Could Be Next New Melanoma Med Approved by FDA, Says Genentech Exec

Published: Jun 01, 2015

ASCO15 EXCLUSIVE: Cancer Drug Could Be First New Med Approved for Melanoma Since 1975, Says Exec
June 1, 2015
By Riley McDermid, Breaking News Sr. Editor

An executive with Genentech told BioSpace Monday that data presented at the American Society of Clinical Oncology (ASCO)’s annual meeting regarding cancer drug cobimetinib is a promising sign that the drug could be the next new treatment for melanoma approved by federal regulators.

The study, dubbed coBRIM, is now part of a push by the firm to have the combo treatment approved by the U.S. Food and Drug Administration (FDA) by August.

“We are waiting for an FDA decision on the combination and expect to hear back by August 11, 2015,” said Josina Reddy, a medical doctor and group medical director for Product Development at Genentech .

Genentech, a member of Swiss drugmaker Roche , presented an ASCO report that showed promising data from two trials of cobimetinib in combination with vemurafenib for the treatment of advanced melanoma. Its Phase III pivotal trial was conducted by Genentech (RHHBY).

The pivotal coBRIM Phase III study showed the combination helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live a median of one year, or 12.3 months, without their disease worsening or death, compared to 7.2 months with Zelboraf alone. The updated results from coBRIM also demonstrated higher response rates with cobimetinib and Zelboraf, compared to Zelboraf alone.

Follow-up data from the Phase Ib BRIM7 study showed cobimetinib plus Zelboraf helped people who had not been previously treated with a BRAF inhibitor live a median of more than two years, or 28.5 months. In addition, extended follow-up showed 61 percent of patients who had not been previously treated with a BRAF inhibitor were alive after two years.

Reddy said the coBRIM Study is part of a wave of new treatments that are revolutionizing the way melanoma is treated.

“Over the past few years, targeted medicines have transformed the way advanced melanoma is treated. With the understanding that BRAF mutations occur in approximately half of all melanomas, targeted therapies continue to have an important role in the treatment of this aggressive disease,” said Reddy.

“Our BRAF inhibitor, Zelboraf, was the first personalized medicine for BRAF V600 mutation-positive melanoma. In developing Zelboraf, we recognized there are mechanisms by which melanoma can become resistant to treatment, which can lead to disease progression,” said Reddy. “We combined Zelboraf with our MEK inhibitor, cobimetinib, to better understand how we could inhibit two proteins (BRAF and MEK) within a major cancer growth pathway with the hope of improving clinical outcomes.”

Reddy said these updated data on cobimetinib and Zelboraf (median PFS of 12.3 vs. 7.2 months with Zelboraf alone) support the potential use of the combination to block tumor growth longer than Zelboraf alone. The updated results also demonstrated a higher rate of tumor shrinkage with the combination – an ORR of 70 percent compared to 50 percent with Zelboraf alone.

Genentech is an industry leader in skin cancer treatment with two FDA-approved medicines for certain types of advanced skin cancer. That broad knowledge is helping the company find new indications for medications in its pipeline, an exciting development for both scientists and executives.

“We are investigating cobimetinib in combination with several investigational medicines, including an immunotherapy, in several tumor types such as non-small cell lung cancer and colorectal cancer,” said Reddy. “People with advanced skin cancer are surviving longer than ever before, in part a result of multiple new medicines approved by the FDA since 2011. Before this, only one new medicine for melanoma had been approved since 1975.”

Will PfizerKline Become the Next Pharma Player?
The speculation surrounding a possible bid from Pfizer Inc. for struggling GlaxoSmithKline is heating up, after one closely-watched biotech analyst said in a note last week that Pfizer buying the company would “unlock access to its balance sheet and improve its tax situation.”

Gregg Gilbert, a biotech analyst at Deutsche Bank, wrote in a note to investors “Introducing PfizerKline” that he thinks a deal would be “materially accretive” for both companies. Gilbert estimated that a bid priced at $29.86 a share, via half stock and half cash, which would push up Pfizer’s earnings per share by 10 percent to 16 percent beginning in 2016.

“We believe that the company has a sense of urgency to create value by leveraging the power of its balance sheet to do needle-moving deals,” Gilbert wrote. “Since media reports in the past have pointed to the potential for a Pfizer/GSK combination, we are revisiting that theme.”

We want to know, dear readers, if you agree? Should Glaxo continue going it alone, or might Pfizer buy it and create one of the world’s largest pharma players in history?

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