It’s not easy being fourth.
The R&D team at AstraZeneca had thought that its single-arm study for its Phase II trial of the PD-L1 checkpoint durvalumab might have offered a shortcut to an approval for second-line head and neck cancer. But Merck easily beat them to the market with Keytruda for head and neck with a nod in August and now Bristol-Myers is breathing down its neck in the hope that they can catapult ahead — which would be welcome after the embarrassing lung cancer debacle.
So now AstraZeneca says it is scrapping plans to file for an early approval in the indication, unlikely to find regulators interested in speeding an OK. Data are expected this quarter, but don’t look for any quick public discussion of what investigators found. The data will be for internal discussion only, and in “due course,” according to AstraZeneca’s Q3 wrap-up.
That leaves AstraZeneca playing catch-up with three combination studies in head and neck cancer, adding the CTLA-4 treatment tremelimumab with durvalumab. But the R&D team has run into a delay here as well after the FDA opted to drop a partial hold on the combos a couple of weeks ago.
The partial hold was instituted after investigators tracked bleeding events in the Phase III program. But the company cautions that all other studies in other cancers are proceeding as planned, noting that such bleeding events are not unusual in head and neck cancer.
That said, AstraZeneca can ill afford any delays in the development of durvalumab/tremelimumab now. The company already delayed its development timeline for the checkpoint inhibitor to allow for combination studies, which AstraZeneca is counting on to make a splash with a late arrival in the field.
Now its chief hope in the field lies in getting its combo approach to regulators for first-line non-small cell lung cancer, ahead of a combination of Opdivo and Yervoy from Bristol-Myers. The first pivotal late-stage data are expected in H1 2017.
It’s been a rough year for AstraZeneca, which has suffered a string of setbacks in 2016. And it’s not getting any easier. Merck, Bristol-Myers and Roche all beat the company to the market with impressive checkpoints, and the Pfizer/Merck KGaA team is also playing catch-up as well.
AstraZeneca also outlined the latest round of programs to get cut out of the pipeline today. The scrap heap list included inebilizumab, its anti-CD19 antibody, for diffuse large B cell lymphoma, MEDI3617 — a selective angiopoietin-2 inhibitor — for solid tumors and cediranib for PSR ovarian cancer. Back in September AstraZeneca pulled its application at the EMA for cediranib, saying that regulators had some differing opinions on the drug’s safety/benefit ratio.
AstraZeneca CEO Pascal Soriot prefers to sweep away setbacks in footnotes, reserving the headline treatment for new pipeline advances. Today, though, the impact of generic competition continued to savage the pharma giant’s revenue numbers, setting a bleak background for Soriot’s trademark R&D bullishness. The company has scored significant progress with two new cancer drugs, Tagrisso and Lynparza, but the company is not making nearly the progress it promised investors when Soriot fended off a takeover attempt by Pfizer. AstraZeneca also posted $674 million in revenue from externalization deals done on assets that have either failed to measure up in the clinic or no longer fit the company’s commercial/R&D focus, which leans heavily on durvalumab.
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