Roche's Tecentriq crosses the finish line first in adjuvant lung cancer, potentially kicking off gold rush
While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.
The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.
The agency based its review on data from the Phase III IMpower010 study, which showed adjuvant Tecentriq cut the risk of relapse or death by 34% over best supportive care. Tecentriq was placed on priority review from the agency in this indication back in early August, making it a speedy turnaround from the FDA.
Tecentriq’s win here could spell blockbuster sales, with some analysts predicting a market opportunity of more than $1 billion for the drug. The approval could also be the first of many in early NSCLC, one of the largest cancer indications in the US, where Tecentriq has carved out a niche despite stiff competition from some of the best selling drugs in the world.
Adjuvant/neoadjuvant immunotherapy care has emerged as a new frontier in the fight between the PD-(L)1s with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo taking home wins of their own across other tumor types. Both drugmakers have hopes in NSCLC as well, with Merck looking at Keytruda as part of the Phase I MK3475-223 study for adjuvant Stage I-II NSCLC.
Meanwhile, Bristol Myers is much further along in its Phase III CHECKMATE-816, testing a combination of Opdivo and chemotherapy as a neoadjuvant — before surgery — therapy for Stage II-III NSCLC.
The drug read out topline data from one of the study’s primary endpoints in April showing the combo posted a 24% pathological complete response rate for patients across the PD-(L)1 expression spectrum compared with just 2.2% for chemo alone. The drugmaker is waiting out results on event-free survival, the study’s second major endpoint, which could set up a filing close after.