FDA taps chemoradio-sensitizing head and neck cancer drug as 'breakthrough'
Years after a family of endogenous proteins known as IAP, or inhibitors of apoptosis proteins, was first linked to poor prognosis of cancer, the FDA is helping move along a drug that blocks it.
Debiopharm’s Debio 1143 now enjoys breakthrough status at the agency, after Phase II results unveiled at ESMO suggested that adding it to a regimen of chemoradiation therapy boosted locoregional control rate as well as progression-free survival among patients with “high risk” locally advanced squamous cell carcinoma of the head and neck.
There have been no newly approved therapies over the last 25 years for this disease, the Swiss biotech noted.
While Debiopharm is positioning the drug as a chemoradio-sensitizer here, it contends that blocking IAP — which prevents programmed cell death — can also have immunomodulatory effects. It’s testing Debio 1143 in combination with Pfizer and Merck KGaA’s Bavencio in non-small cell lung cancer.
Merck and partners at Stockholm-based Medivir have previously tested an IAP inhibitor dubbed birinapant with Keytruda, only to shut the Phase II down following a futility analysis.
AstraZeneca, Novartis, Roche, Boehringer Ingelheim and a crop of biotechs all have early-stage drugs that target either IAP broadly or survivin — a member of the family — specifically in their pipeline, according to PharmCube.
Debiopharm is planning a pivotal Phase III trial for Debio 1143 and chemoradiation therapy in head and neck cancer later this year.