AstraZeneca is officially on the board with checkpoint inhibitor Imfinzi (durvalumab), which nabbed its first FDA approval Monday.
The British pharma giant picked up an accelerated green light in urothelial carcinoma, and with it, it becomes the third Big Pharma player to enter the advanced bladder cancer space with a PD-1/PD-L1 inhibitor. Imfinzi will take on established player Tecentriq from Roche, which hit the scene last May, and Opdivo, the Bristol-Myers Squibb entrant that won its bladder go-ahead in February. Merck is still chasing a bladder cancer nod for its contender, Keytruda.
Imfinzi, though, will roll out at a higher price point than its nemeses; the estimated average monthly cost of the med will be $13,000, a spokeswoman said in a statement, compared with its rivals' $12,500. That translates to a yearly price of $156,000 for the AstraZeneca newcomer, though the spokeswoman stressed that the price "will vary based on an individual's health insurance status" and "the WAC price is rarely the price paid by an individual patient."
The approval comes based on a single-arm, 182-patient trial, which produced an overall response rate of 26.3% among the 95 patients with high PD-L1 scores. As Tecentriq does, Imfinzi goes hand in hand with a complementary diagnostic from Ventana that assesses PD-L1 levels in tumors.
But that’s not the only similarity AZ hopes to have with its Swiss rival. Roche has already broadened the eligible patient pool for Tecentriq, picking up an approval last month in patients ineligible for cisplatin chemo. And more importantly, Tecentriq has already broken into the lung-cancer space, which represents the largest opportunity for the checkpoint group.
That’s an act AstraZeneca is currently working to follow; it’s testing Imfinzi both as a monotherapy and in tandem with tremelimumab, a CTLA-4 candidate, in first-line patients. It’s a route Bristol has also taken with Opdivo and CTLA-4 med Yervoy following the med’s flopping of a first-line monotherapy study.
Merck and Roche, though, are pairing their lung-cancer fighters with chemo meds, and it remains to be seen which approach will pay off. A recently delayed readout for the durvalumab-tremelilumab duo in the third-line setting, though, set off alarm bells for Bernstein analyst Tim Anderson, who posited that AZ's slowdown could signal “a negative trial.”
“We have been worried this trial will likely fail, which could have a partial negative read-through” to the first-line combo study, Mystic, he wrote to clients last week, “but timing has (conveniently?) been pushed back now, deferring this issue.”
Meanwhile, AZ will gladly take any sales boost Imfimzi can provide as it works to claw its way out of a serious patent hole. For the first quarter, the company’s $4.84 billion in product sales missed analysts’ $4.92 billion predictions, with generics taking a greater-than-expected toll on antipsychotic Seroquel and the company’s growth products—including blood thinner Brilinta, cancer fighter Lynparza and diabetes drug Farxiga—falling short of expectations.
Editor's note: This story has been updated with Imfinzi pricing information.