{"id":3908,"date":"2026-10-26T09:00:00","date_gmt":"2026-10-26T13:00:00","guid":{"rendered":"https:\/\/www.insilens.com\/?p=3908"},"modified":"2026-10-26T19:30:34","modified_gmt":"2026-10-26T23:30:34","slug":"hansoh-met-combination-improves-pfs-after-egfr-therapy","status":"publish","type":"post","link":"https:\/\/www.insilens.com\/?p=3908","title":{"rendered":"Hansoh MET Combination Improves PFS After EGFR Therapy"},"content":{"rendered":"

\"\"<\/p>\n

Company<\/strong><\/p>\n

Hansoh Pharma<\/p>\n

Event Type<\/strong><\/p>\n

Phase 3 data disclosure<\/p>\n

Modality<\/strong><\/p>\n

Oral MET inhibitor plus third-generation EGFR inhibitor<\/p>\n

Asset<\/strong><\/p>\n

Dalmelitinib plus aumolertinib (HS-10241-301)<\/p>\n

Target<\/strong><\/p>\n

MET; EGFR<\/p>\n

Disease Area<\/strong><\/p>\n

EGFR-mutant, MET-amplified NSCLC after EGFR-TKI failure<\/p>\n

Summary<\/h4>\n

Hansoh disclosed a statistically significant PFS result for dalmelitinib plus aumolertinib versus platinum chemotherapy in a China Phase III trial of EGFR-mutant, MET-amplified NSCLC after EGFR-TKI failure. Absolute median benefit was 1.8 months; overall survival is immature.<\/p>\n

HS-10241-301 randomized 314 patients 1:1, about 95% previously exposed to a third-generation EGFR TKI. MET amplification was defined by FISH gene copy number at least 5 or MET\/CEP7 ratio at least 2. At 11.2 months median follow-up, BICR median PFS was 6.2 versus 4.4 months (HR 0.601, 95% CI 0.448\u20130.805; P<0.001), and response was 59.6% versus 38.6%. OS HR was 0.84 (95% CI 0.524\u20131.346) at 22.9% maturity; 46.8% of chemotherapy patients crossed to the combination. Grade-3-or-higher ALT and AST elevations occurred in 12.8% and 9.6% on combination. The China NDA was accepted on 27 February 2026; this is a new detailed data presentation, not a new approval.<\/p>\n

Deep Analysis<\/h4>\n

The biologic rationale mirrors post-EGFR resistance: dual kinase blockade may suppress MET bypass while continuing EGFR control. Blinded central PFS review mitigates an open-label design. The absolute PFS gain is modest, however, and the immature OS point estimate cannot support a survival claim. High control-arm crossover may complicate later OS interpretation. The trial used a lower MET amplification threshold than the global SAFFRON study, selecting a broader and potentially less MET-dependent population; the two trials cannot be compared numerically. Hepatic enzyme elevations and treatment exposure affect the net clinical tradeoff. China-only development and different diagnostic thresholds limit immediate portability to US or European care. The original Chinese announcement was dated 26 October; English company syndication also appeared 26 October.<\/p>\n

Company and Product Background<\/h4>\n

Dalmelitinib is Hansoh\u2019s oral selective MET inhibitor; aumolertinib is its third-generation EGFR inhibitor. The combination targets MET-mediated bypass resistance after EGFR-directed treatment in metastatic non-small-cell lung cancer.<\/p>\n

Signal Extraction<\/h4>\n
    \n
  • Interpretation A:<\/strong> a locally available EGFR\u2013MET oral regimen benefits a broad MET-amplified post-TKI group; randomized PFS and response support it.<\/li>\n
  • Interpretation B:<\/strong> broader biomarker entry dilutes benefit and may produce less meaningful patient outcomes; small absolute PFS gain and immature OS support caution.<\/li>\n
  • Upgrade:<\/strong> mature survival and quality-of-life data, assay-level outcomes, full liver-safety tables and external replication. Downgrade:<\/strong> no OS improvement with follow-up or clinically limiting hepatotoxicity. Falsification:<\/strong> no benefit in prospectively confirmed MET-amplified disease on independent testing.<\/li>\n<\/ul>\n

    InSilens Take<\/h4>\n

    Inference: Hansoh offers a plausible China-market precision alternative, but today\u2019s evidence does not show superiority to other EGFR\u2013MET strategies.<\/p>\n

    Signal Assessment<\/h4>\n

    Signal Importance: 4 of 5. Signal Direction: positive for PFS; OS uncertain. Confidence in Facts: high. Confidence in Interpretation: moderate.<\/p>\n","protected":false},"excerpt":{"rendered":"

    Hansoh disclosed a statistically significant PFS result for dalmelitinib plus aumolertinib versus platinum chemotherapy in a China Phase III trial of EGFR-mutant, MET-amplified NSCLC after EGFR-TKI failure. Absolute median benefit was 1.8 months; overall…<\/p>\n","protected":false},"author":1,"featured_media":3918,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[1222,1221,1220,1223,1107],"class_list":["post-3908","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-therapeutic-indication","tag-aumolertinib","tag-dalmelitinib","tag-hansoh","tag-met-amplification","tag-phase-3"],"blocksy_meta":[],"_links":{"self":[{"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/posts\/3908","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.insilens.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=3908"}],"version-history":[{"count":1,"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/posts\/3908\/revisions"}],"predecessor-version":[{"id":3924,"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/posts\/3908\/revisions\/3924"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/media\/3918"}],"wp:attachment":[{"href":"https:\/\/www.insilens.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3908"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.insilens.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3908"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.insilens.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3908"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}