Drug Development

Lagging further behind, AstraZeneca adds fresh details to its checkpoint comeback strategy

AstraZeneca has sketched out some fresh details on its mission critical pivotal study on its checkpoint drug approach to non-small cell lung cancer, mapping another likely delay as the pharma giant looks for its first big opening in the megablockbuster cancer market.

The MYSTIC study has been enrolling lung cancer patients regardless of PD-L1 expression status. In its statement today the pharma giant says it will evaluate progression-free survival as well as overall survival for durvalumab combined with tremelimumab — its all-important I/O + I/O matchup that will look to outperform the therapies already approved for frontline and second line patients — for all comers as well as PD-L1 expressers. And it will also now explore the data for durvalumab as a monotherapy.

Seamus Fernandez, Leerink

Data are expected now mid-year for PFS and no later than sometime in 2018 for OS, which Seamus Fernandez at Leerink counts as a three-month delay:

“In the wake of MRK’s (MP) surprise filing announcement for its Keytruda (pembrolizumab; anti-PD-1) + chemotherapy combination, AZN’s decision to focus on MYSTIC’s best chance of success with either mono- or combo therapy is rational, in our view,” Fernandez noted. “In addition, the company’s strategic update on immuno-oncology (IO) monotherapy (PEARL study) and combo therapy (expanded NEPTUNE recruitment) provides another substantial shot on goal for the company’s global IO efforts.”

The NEPTUNE study will be used to seek an OK in China for first-line use based on earlier PFS data while the newly launched PEARL will go after PD-L1 expressers in Asian markets, where the rate of NSCLC runs high.

Merck stunned the market recently when it sped through a filing for a combination of Keytruda with chemotherapy in frontline NSCLC, putting some fresh distance between its big checkpoint and Bristol-Myers Squibb’s rival Opdivo. Roche was the third player on the market with Tecentriq, which is also involved in multiple studies.

AstraZeneca, which stumbled through a series of mishaps last year, desperately needs to do something right with durvalumab to at least partially satisfy some big promises CEO Pascal Soriot has made to investors. A late arrival to the checkpoint market, either alongside or right behind Pfizer, leaves AstraZeneca with shrinking opportunities for making a splash.

It’s still possible, though, and analysts aren’t counting the company out.

“While Keytruda is now approved in 1L patients with PD-L1 expression of 50% or higher, there remains “white space” for durva in PD-L1+ patients with lower (but still positive) expression,” reports Fernandez.


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RAPS Regulatory Convergence 2017