Roche’s Tecentriq appeared on the immuno-oncology scene in May of this year, approved to treat bladder cancer and trailing Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo by more than a year. But with new data in a lung cancer study, it appears Tecentriq will soon close the gap in the market-share race despite its late entry.
Roche ($RHHBY) today announced that patients taking Tecentriq showed significantly improved overall survival, regardless of their PD-L1 status, compared with those getting chemo for locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease had progressed while or after they had received the platinum-based chemotherapy.
The data comes just weeks after BMS ($BMY) stunned markets with its news that Opdivo had failed to hit endpoints in a trial as a first-line treatment in lung cancer, the most valuable for a monotherapy.
Bernstein analyst Tim Anderson’s reading of today’s announcement is that immuno-oncology “is now a three company affair” and Roche’s Genentech is now a “strong competitor with an established commercial presence and marketing muscle to offset its third-to-market entry timing.”
In fact, Anderson told clients in a note that today’s news creates a possible scenario where Tecentriq is blessed with full FDA approval for all second-line patients, which would give it a label indication equivalent to Opdivo and separate it from Merck’s ($MRK) Keytruda, which requires PD-L1 testing. The FDA is expected to decide on the indication Oct. 19.
“While this would not change the timing of market access, it would strengthen its market impact,” Anderson said, with Bristol-Myers’ Opdivo taking the bigger hit.
Bernstein is now estimating Tecentriq revenues of $4.9 billion in 2021, assuming it gets approval for treating non-small cell lung cancer and colon cancer as well as bladder cancer. It is forecasting Opdivo at $8.1 billion and Keytruda at $6.5 billion, with AstraZeneca’s ($AZN) yet to be approved PD-L1 checkpoint inhibitor running a distant fourth, but still a blockbuster, at $1.8 billion.
The market is expected to separate out further as each of the company’s pairs their drugs up with others to create combo treatments that may prove even more effective for certain patients. Anderson has said that it may be in combo drugs where the real fortunes are made.