MADRID — Just weeks after AstraZeneca was hammered by a round-one failure for its checkpoint combo on non-small cell lung cancer, the pharma giant repaired some of that damage at ESMO with an impressive hit for a blockbuster market segment.
Tackling stage 3 lung cancer, AstraZeneca’s top execs turned up in Madrid to unveil data from their PACIFIC trial which revealed a progression-free survival advantage of more than 11 months for a group of patients taking Imfinzi (durvalumab) over placebo— 16.8 versus 5.6 months. That represents a 48% drop in the risk of progression.
Researchers treated patients whose cancer was inoperable and had not advanced widely in the body following standard chemo therapy in stage 3. That wasn’t the big score they have been looking for with a combo of Imfinzi and tremelimumab for first-line therapy, but it represents a blockbuster prize for a company that has been making some major advances in oncology in recent years.
“We’re going to be first in half the pool in lung cancer,” AstraZeneca CEO Pascal Soriot told a small group of reporters on Friday.
AstraZeneca’s shares surged 2% in after-market trading on Friday after the numbers hit.
Stage 3 itself represents a third of NSCLC incidence, and Soriot with chief medical officer Sean Bohen explained that it positioned Imfinzi as the lead checkpoint in the front half of the market for stages 1 through 3, with a strategic advantage for moving into stage 4 cases.
Soriot demurred on giving his own estimate of what that is worth, sticking with the company’s ballpark figure of $1 billion-plus. But he also cited a market consensus that a win in this group could spur sales of more than $2 billion a year.
Soriot added that he felt that looking over the market, AstraZeneca has a wide open shot at seizing the advantage for two years before a rival could come along in that particular arena.
The pharma giant has already sent in its marketing application on this, with a breakthrough therapy designation at the FDA which could be swiftly acted on by regulators who have been quick to wave through new approvals for these approved checkpoints.
“Having stage 3 to ourselves is really critical,” says Soriot, who needed this win. “I think in lung cancer we can be a leader.”
Merck is still out front in the field with its OK for Keytruda with chemo in front-line lung cancer, after leapfrogging a damaged Bristol-Myers Squibb. But the AstraZeneca advance at ESMO underscores just how much near-term potential is still at stake as the leaders in the PD-(L)1 field continue to jockey for top spots in various segments of the cancer market.
With an OK here, Soriot and Bohen underscored that the introduction of Imfinzi was “practice-changing” — with physicians able to simply add it to the standard of care. A new treatment option like this should also help improve earlier screening practices, they said, getting to more of the patients before they fall into the advanced stage 4 pool, which represents the other half the market, and potentially tipping more of the market in their favor.
A win here positions AstraZeneca to stake out more blockbuster territory in oncology after making solid progress in establishing Lynparza and Tagrisso in their respective fields. Together those three drugs represents Soriot’s commitment to creating a major cancer drug franchise that will be essential for turning around the company after years of waning revenue.
AstraZeneca is not out of the woods yet, but things are looking up for Soriot this weekend after some bleak setbacks earlier in the year.
— Carlos Alvarez (@duemed) September 8, 2017
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