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Investors are Antsy After Roche (RHHBY) Suffers Another Late-Stage Trial Flop



9/11/2017 6:01:13 AM

Investors are Antsy After Roche Suffers Another Late-Stage Trial Flop September 11, 2017
By Alex Keown, BioSpace.com Breaking News Staff

BASEL, Switzerland – Bad luck continues for Roche (RHHBY) as another drug fails to meet endpoints.


This weekend, Roche said its Phase III drug Zelboraf (vemurafenib) failed as a post-surgical treatment for patients with Stage IIIC skin cancer. Roche said kinase inhibitor Zelbroaf did not meet primary endpoints of significantly reducing the risk of recurrence in patients with completely resected, BRAF V600 mutation-positive melanoma. Although the drug failed with State IIIC, Roche said Zelbroaf did bring about a 46 percent reduction in recurrence risk in stage IIC-IIIB patients.

The company said one of the cohorts, the IIIC cohort, in the trial did not meet the disease free survival goal compared to placebo. The first cohort, which included the IIC-IIIB patients demonstrated a median DFS of 23.1 months with Zelboraf vs. 15.4 months with placebo. However, Roche said “due to the pre-specified statistical design of the study, the results for cohort 1 cannot be formally tested for significance.”

“While results in people with stage IIIC melanoma were not what we had hoped, the reduction in the risk of recurrence in people with stage IIC-IIIB disease is encouraging and suggests Zelboraf may play a role in this earlier setting,” Sandra Horning, Roche’s chief medical officer and head of global product development, said in a statement.

Roche’s failure though was amplified by Novartis announcing its drug succeeded in the same space. Novartis announced today that the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) yielded a 53 percent reduction in the risk of death or recurrence in patients treated with the BRAF and MEK inhibitor combination therapy versus placebo.

Shares of Roche dropped on the news, falling from Friday’s closing price of $244.50 to $241 this morning.

Zelboraf was first approved in 2011 for the treatment of BRAF V600E mutation-positive, inoperable or metastatic melanoma. The drug’s failure for a new indication is the latest in disappointing results that have recently troubled the pharma giant. Last week Genentech (RHHBY), a subsidiary of Roche, announced its Phase III eye drug lampalizumab failed. Lampalizumab was being assessed as a treatment for geographic atrophy (GA) due to age-related macular degeneration (AMD). Analysts predicted the drug could have generated billions of dollars in revenue annually had it succeeded.
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In July, the company announced it was reprioritizing its pipeline following a string of failed drug trials and challenges from the growing biosimilar market. That month the company ended a collaborative deal with Spanish biotech Oryzon Genomics for leukemia and cancer treatments. In May, the company announced Tecentriq (atezolizumab) surprisingly failed to meet its primary endpoint in its Phase III IMvigor2011 clinical trial. That followed an April announcement that Roche was dropping a cancer line it gained from its 2014 acquisition of Seragon Pharmaceuticals.

Despite the bumps, Roche and Genentech have taken in recent months John Rountree, partner at Novasecta, told CNBC that the company’s investments in R&D are likely to see Roche through any turbulence.

"I think they've got a viable strategy. They're continuing to innovate and they're investing a lot in R&D...the biosimilar (an almost identical biologic copy of an original drug) is a threat to them and they've just got to work harder. You're going to get trial setbacks but they've just got to keep ploughing ahead with that innovation," Rountree told CNBC.

Although it has seen some setbacks, Roche has also seen some positives as well. In March, Roche and its subsidiary Genentech snagged regulatory approval for its new multiple sclerosis drug Ocrevus. It is the first and only approved disease-modifying therapy for primary progressive form of MS.


Read at BioSpace.com


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