Boehringer Ingelheim International GmbH / Hanmi Pharmaceutical Co., Ltd. (HM61713 program)

T790M-Mutant EGFR Non-Small Cell Lung Cancer (NSCLC)

30K US cases/yr

Disease Overview

EGFR mutations occur in ~10-15% of US NSCLC adenocarcinoma cases and are enriched in Asian, female, never-smoker populations (~30-40% prevalence in Asian NSCLC). First-line EGFR-TKIs (gefitinib, erlotinib, afatinib) drive responses but resistance emerges typically within 9-13 months, with the T790M gatekeeper mutation accounting for ~50-60% of acquired resistance — the precise biomarker third-generation EGFR-TKIs were designed to address.

Competitive Landscape

When Boehringer Ingelheim signed the $730M Hanmi olmutinib deal in July 2015, AstraZeneca's osimertinib (Tagrisso) was the unambiguous category leader — FDA accelerated approval came in November 2015 (months after deal signing), and full approval plus head-to-head data versus erlotinib/gefitinib (FLAURA) followed in 2018. Olmutinib (HM61713 / BI 1482694) was the closest-in challenger with comparable Phase 2 efficacy (54% ORR, 6.9-month mPFS in T790M+ NSCLC) but trailed Tagrisso by ~12-18 months in development timeline. The deal collapsed when serious dermatologic toxicity emerged in Boehringer's Phase 2 — two fatal Stevens-Johnson syndrome / toxic epidermal necrolysis events were reported, plus interstitial lung disease (ILD) signals. South Korea's Ministry of Food and Drug Safety issued a safety letter on September 30, 2016, the same day Boehringer terminated the partnership and returned global rights ex-Korea/China/HK to Hanmi. Hanmi retained $65M in upfront/milestone payments. Fierce Biotech ('Hanmi calls time on troubled Tagrisso rival olmutinib') and BioSpace covered the unwinding as a clear safety-driven failure that ceded the third-gen EGFR-TKI category to Tagrisso, which by 2026 is the backbone first-line and adjuvant EGFR NSCLC standard. Hanmi formally terminated olmutinib development on April 13, 2018. Sources: https://www.fiercebiotech.com/biotech/hanmi-calls-time-troubled-tagrisso-rival-olmutinib ; https://www.biospace.com/deaths-lead-boehringer-ingelheim-to-cancel-730-million-cancer-deal-with-hanmi-pharma-b-hanmi-b-stock-tanks