Roche snags an FDA approval for an advanced melanoma drug cocktail — but it’s up against some fierce competition

Roche’s PD-L1 inhibitor Tecentriq snagged an FDA approval to treat certain advanced melanoma patients in a three-drug cocktail, providing another option for patients with a typically poor prognosis.

In a Phase III IMspire150 study, Tecentriq combined with Cotellic (cobimetinib) and Zelboraf (vemurafenib) significantly beat a placebo mix in extending progression-free survival in BRAF V600 mutation-positive advanced melanoma patients. Participants on Tecentriq lived a median 15.1 months without worsening disease, compared to 10.6 months in patients on Cotellic, Zelboraf, and the placebo.

Those are all perfectly good numbers, but they’re likely not good enough to move the needle in this market niche, where Roche will butt heads with the dominant rivals who reshaped treatment standards in the field.

Merck’s Keytruda and Bristol Myers Squibb’s Opdivo — both of which got DA green lights in 2014 — pose tough competition. When researchers tested the effectiveness of Cotellic and Tecentriq alone in treatment-naive patients, they found the cocktail didn’t measure up to Keytruda’s standard of care. And a five-year check-in on a Bristol Myers Squibb clinical trial showed patients who were given both Opdivo and Yervoy had a 52% survival rate, as opposed to 44% for just Opdivo, or 26% for just Yervoy.

Stifel analyst Stephen Willey has said the Tecentriq triple-drug cocktail is more of a “check the box” than “expand the market” move.

“When receiving a cancer immunotherapy combined with targeted therapies, patients with BRAF V600 mutation-positive advanced melanoma were able to live for more than 15 months without their disease worsening,” Levi Garraway, Roche CMO and head of global product development, said in a prepared statement. “Today’s FDA approval of this Tecentriq combination represents an important step forward for many patients living with advanced melanoma.”

Tecentriq is currently prescribed to treat non-small cell lung cancer. Last year, it became the first immunotherapy approved for triple-negative breast cancer patients who are metastatic and PD-L1 positive. In current and future Phase III trials, Genentech will test Tecentriq’s use alone and in cocktails for various lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers.

Cotellic, an Exelixis drug, is being co-developed with Roche.  The Swiss pharma also has a clinical collaboration agreement to develop Zelboraf, which was a Plexxikon drug before the company was acquired by Daiichi Sankyo.

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