Hanmi Pharmaceutical Co. Ltd. / Boehringer Ingelheim GmbH

EGFR T790M-mutant Non-Small Cell Lung Cancer

Disease Overview

EGFR T790M-mutant NSCLC is acquired resistance to first- and second-generation EGFR TKIs (erlotinib, gefitinib, afatinib) that emerges in roughly 60% of patients who progress on those agents. Because the resistance allele blocks ATP binding by earlier inhibitors, T790M patients have very limited options without a third-generation, mutation-selective TKI.

Competitive Landscape

AstraZeneca's Tagrisso (osimertinib), approved by the FDA in November 2015 for metastatic T790M-positive NSCLC, defined the third-generation EGFR TKI market and rapidly became the de facto standard of care once data and access were established globally. Olmutinib (HM61713 / Olita), Hanmi's irreversible mutation-selective TKI, was a direct rival licensed to Boehringer Ingelheim in July 2015 for $730M and approved in South Korea in May 2016, but its commercial path collapsed after Korean regulators flagged toxic epidermal necrolysis (one fatal) and Stevens-Johnson syndrome cases on September 30, 2016. Boehringer terminated the same day citing 're-evaluation of all available clinical data on olmutinib and recent treatment advances,' explicitly conceding olmutinib was no longer competitive versus Tagrisso. Other third-gen candidates in development at the time included Clovis's rociletinib (later abandoned after FDA's 2016 ODAC and CRL) and ASP8273. The deal termination cleared the field for Tagrisso, which has since expanded into 1L EGFR-mutant NSCLC and combination chemo regimens, generating ~$6B in annual sales by 2024. For Hanmi, the collapse cost up to $680M in milestones, though Hanmi retained the $50M upfront and continued limited Korean supply.