Roche’s PD-1 rivals got their starts in the melanoma market all the way back in 2014. But for the Swiss drugmaker’s Tecentriq, Thursday marked its entry into the field.
The FDA green-lighted a combination of Tecentriq and targeted meds Cotellic and Zelboraf in patients with BRAF V600-mutated advanced melanoma, Roche said. Regulators based the go-ahead on data from the phase 3 IMspire150 trial, which showed that adding Tecentriq to the Cotellic-Zelboraf pairing slashed patients’ risk of disease progression or death by 22%.
In that study, patients on the Tecentriq cocktail went a median 15.1 months without their cancer worsening, versus 10.6 months for patients receiving the doublet therapy.
But despite the rosy results, analysts don’t necessarily expect the trio to become a big seller. In a note to clients late last year, Stifel analyst Stephen Willey called IMspire150 "more of a ‘check the box’ vs. an ‘expand the market’ exercise.”
The reason? Stiff competition. Both Merck’s Keytruda and Bristol Myers Squibb’s Opdivo broke onto the melanoma scene nearly six years ago, and since then they’ve completely changed the treatment landscape. In particular, BMS’ Opdivo-Yervoy combo—cleared to treat patients with and without BRAF mutations—has been a hit, showing last year that it could keep more than half of patients alive for more than five years.
Luckily for Roche, melanoma isn’t Tecentriq’s only new market. In late May, a combination of the drug and Roche’s Avastin scored an approval in previously untreated liver cancer, setting it up to take on longtime king Nexavar from Bayer—a treatment Roche’s duo trounced in a head-to-head clinical trial.