Haihe takes on Orpathys in China

Like its rival c-Met inhibitor Orpathys, Haihe Biopharma's Haiyitan (gumarontinib) holds China approval in first-line lung cancer with a c-Met exon 14 skipping mutation, and now Haihe is following the more advanced Hutchmed/AstraZeneca drug into a first-line Tagrisso combo setting. Here a phase 2/3 study has just started, according to a new clinicaltrials.gov listing, investigating gumarontoinib plus Tagrisso in patients whose NSCLC tumours have an EGFR mutation as well as c-Met overexpression or amplification – mirroring the Sanovo trial of Orpathys that's due to read out in the second half of this year. Not only that, but Orpathys plus Tagrisso is awaiting China approval for second-line NSCLC, a setting where Haihe put gumarontinib plus Tagrisso into phase 3 in February. This is a China-focused battle, and gumarontinib isn't actively being developed in the west, where a different dynamic exists, and where Novartis's Tabrecta and Merck KGaA's Tepmekto are approved in exon 14 settings that yield minimal revenues. Orpathys development is being pursued in the west, but this seems to be an effort by Astra to secure Tagrisso against competition from Johnson & Johnson's anti-EGFR x c-Met bispecific antibody Rybrevant.

Selected trials of c-Met inhibitors in NSCLC

Source: OncologyPipeline.