The FDA is putting an oral lung cancer drug from Boehringer Ingelheim on its inside track, promising to accelerate development of a new EGFR mutation-specific tyrosine kinase inhibitor that could quickly rival competing therapies from AstraZeneca ($AZN) and Clovis Oncology ($CLVS). And Boehringer is promising to hustle its way through a pivotal program with an eye to a near-term launch.
Boehringer won the agency's breakthrough therapy designation for BI 1482694, which demonstrated early-stage promise for T790M-positive cases of non-small cell lung cancer. That's the same target that AstraZeneca hit for the recent approval of the pioneering TKI Tagrisso (AZD9291). And Clovis has been in hot pursuit with rociletinib (CO-1686), which has now been dragged back by deteriorating patient responses and a delay at the FDA.
In Boehringer's early human study, investigators tracked a 62% objective response rate among patients earlier this year, though the median duration of response had not been established by the cutoff point for data.
Boehringer is targeting the T790M patient group in a pivotal Phase II and says it plans a full slate of Phase III studies that will launch next year.
Boehringer says that the drug is being designed as a next-gen followup for patients who become resistant to currently available therapies. If all goes according to plan, the drug can be introduced after Tagrisso gets the first mover advantage, with Clovis still angling to gain market access as it sorts out its data at the FDA.
The FDA clearly loves this target. Both Tagrisso as well as rociletinib won BTD titles at the FDA, which may lead some to wonder why follow-up therapies in the same space should be designated as 'breakthroughs" as well.
"The T790M mutation is the most common resistance mechanism found in about half of the patients previously treated with currently available EGFR TKIs," says Dr Mehdi Shahidi, medical head, solid tumor oncology, Boehringer Ingelheim. "Our aim at Boehringer Ingelheim is to prolong the continuum of treatment with targeted therapies for patients with EGFR mutation-positive lung cancer with a treatment that could potentially be efficacious even after the inevitable occurrence of resistance to the initial treatment."
- here's the release