Results

ASCO17: AstraZeneca pumps up expectations on near-term cancer drug wins, looking to shed a rep for failure

CHICAGO — AstraZeneca’s R&D team arrived at ASCO on a critical mission.

With its leading PARP inhibitor outscoring chemo in treating breast cancer,  making the spotlight round on Sunday, AstraZeneca was able to offer some fresh, solid evidence of its continuing progress on the all-important cancer front. And with several key catalysts lined up over the summer, execs wanted to send a clear message that this cancer drug roll they’re on is just beginning.

As far as Leerink’s Seamus Fernandez is concerned, AstraZeneca’s investor meeting in Chicago was a rousing success, with some suggestions that the pharma giant is on the verge of offering some ‘practice changing’ advances in the field.

Sean Bohen, AstraZeneca

AstraZeneca execs left the crowd with the clear impression that Lynparza was on its way to a broad approval for second-line maintenance therapy in treating ovarian cancer. R&D chief Sean Bohen also hinted that the full readout on the PACIFIC trial — Imfinzi monotherapy following chemo and radiation in Stage 3 non-small cell lung cancer — will be a hit. Fernandez noted:

Based on this and comments from previously interviewed KOLs, we believe the results are likely to be both clinically meaningful and practice-changing. AZN estimates a Stage III NSCLC incidence of ~100k per year, with about half being unresectable. With other PD-1/L1 inhibitors ~2-3 years behind in the setting, this represents a large market-expanding opportunity for Imfinzi.

Fernandez believes that the pharma giant has already filed its BTK drug acalabrutinib for an approval at the FDA and is just waiting for confirmation that the package has been accepted for review. Peak sales estimates for this drug scrape the $1 billion mark— possibly making it one of the top 10 orphan drugs in the late-stage pipeline — which would make it a valuable addition to the portfolio.

And then there’s MYSTIC, AstraZeneca’s combo of its checkpoint Imfinzi (durvalumab) and tremelimumab, a CTLA-4 drug. Over the past few months there’s been a growing sense that this combination could well flounder on CTLA-4’s well-known toxicity. But AstraZeneca’s team is keeping their smiles in place, trying to assure everyone that this program remains on track, with plenty of potential to impress.

The data are expected in a matter of weeks now, so this mystery won’t play long. A success here would make a huge difference for the multinational, which has been dogged by clinical setbacks for years now. Some assurance that CEO Pascal Soriot’s big bet on cancer is paying off with a multibillion-dollar return would go a long way to assuring analysts that the long-awaited turnaround is near.

Failure would likely blight the process once again.


The best place to read Endpoints News? In your inbox.

Full-text daily reports for those who discover, develop, and market drugs. Join 17,000+ biopharma pros who read Endpoints News by email every day.

Free Subscription

RAPS Regulatory Convergence 2017