Amgen fails to show or tell with Kras update

Biopharma press releases rarely conjure thoughts of burlesque, but yesterday Amgen left observers wanting a lot more. The group said a “potentially registrational” phase II trial of its closely-watched Kras inhibitor, sotorasib, in advanced lung cancer was positive, without disclosing any data. All Amgen revealed was that response rates were consistent with phase I data; most recently presented at Esmo, these showed a 35% ORR and a median duration of response of 10.9 months. Analysts believe that DOR needs to hit at least six months in phase II to give sotorasib a chance at early approval, and the sellside widely interpreted Amgen’s release to mean that this had been achieved, and even beaten; Leerink went so far as to predict that 10-11 months could emerge. It will be a while before the numbers from the phase II portion of the Codebreak 100 study are revealed – full data are not due until January, at the World Lung conference. Amgen did give a clear hint that it believes the data are good enough to file on, however, saying that talks with regulators will now commence. A thin late-stage pipeline explains Amgen’s need for speed here; the Kras inhibitor is the group’s third most valuable pipeline project, according to EvaluatePharma.