Roche's triplet involving Tecentriq clears the PFS bar for melanoma when added to BRAF/MEK combo
In a “check the box” exercise, Roche said it has shown that adding Tecentriq to a combo of Cotellic and Zelboraf was effective in extending progression-free survival in melanoma patients compared to placebo plus the two drugs.
Patients with previously untreated BRAF V600 mutations were recruited to the Phase III study, dubbed IMspire150.
Cotellic (which was initially developed by Roche partner Exelixis) and Zelboraf are already approved to treat BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma. While the latter blocks some BRAF kinases, the former is believed to help break treatment resistance by also inhibiting MEK1/2.
Sometimes, though, that’s still not enough, thus the attempts to add a third agent to increase the durability of treatment — either a targeted therapy or, in this case, an immunotherapy.
Roche has tried to test a combo of Tecentriq plus just Cotellic for treatment-naive cases, but that combination failed to beat standard-of-care Keytruda in a separate trial, IMspire170, unveiled earlier this year.
The pharma giant recorded around $44 million in Cotellic sales in the first three quarters of 2019, while Tecentriq fetched over $1.3 billion.
Cotellic and Zelboraf had two heavyweight rivals in Novartis, which markets Mekinist and Tafinlar, as well as Pfizer after it snapped up Array and its Mektovi/Braftovi pairing. All players are looking to go beyond melanoma now — Pfizer is especially keen about the prospects in colorectal cancer — though Roche has suffered some setbacks.
Stifel analyst Stephen Willey has previously described the triplet vs doublet comparison as more of a “check the box” than “expand the market” move.
The next step will be to check the regulatory box.
“By combining a cancer immunotherapy with targeted therapies, we hope to offer a new approach that improves outcomes for people with advanced, BRAF-mutant melanoma,” CMO Levi Garraway said in a statement.