Boehringer Ingelheim has backed out of the $730 million (€650 million) lung cancer pact it struck with Hanmi Pharmaceutical last year. The decision follows a reevaluation of available clinical data and the competitive landscape, a process that led Boehringer to conclude it should cut its losses and focus on other pipeline programs.
The news comes four months after Boehringer unveiled what it described as an “ambitious” clinical trial program designed to build on “the encouraging clinical data” generated by the third-generation EGFR therapy olmutinib in non-small cell lung cancer (NSCLC) to date. At that time, Boehringer was talking up the prospects of pairing the drug with Merck’s ($MRK) anti-PD-1 therapy Keytruda and was set to initiate two Phase III trials before the end of the year.
A fresh look at old data has scuttled those trials before they even started. Whatever Boehringer learnt in its reevaluation of the clinical data and analysis of the competitive landscape in EGFR mutation-positive lung cancer has caused it to toss out the plan.
Rather than start clinical trials of olmutinib, Boehringer will return development rights and responsibilities to Hanmi, which is currently testing the drug in three Phase I/II and Phase II trials. Boehringer came on board as a co-sponsor of those trials, but only ran a Phase I pharmacokinetic study itself. That Phase I in healthy volunteers is the only study listed on ClinicalTrials.gov as having started or finished in the brief period in which Boehringer was involved with olmutinib.
The period saw Hanmi win approval in South Korea and share data from an ongoing Phase I/II trial at the 2016 ASCO Annual Meeting. In that analysis of 70 evaluable NSCLC patients who had already received treatment with an EGFR tyrosine kinase inhibitor (TKI), 54% experienced a partial response. Boehringer unveiled its clinical development plan for olmutinib the day before Hamni presented the data, suggesting it was confident enough in the results to commit to further development at that time.
Since then, AstraZeneca’s ($AZN) EGFR TKI Tagrisso hit the primary endpoint in a Phase III second-line NSCLC trial, Roche’s ($RHHBY) Genentech posted Phase III NSCLC data on its EGFR-suitable PD-L1 inhibitor and Merck shared first-line NSCLC data on its PD-L1 drug Keytruda. Somewhere along the line Boehringer lost confidence in olmutinib.
When Boehringer struck the deal in July 2015, it handed over $50 million and committed to $680 million in milestones to gain the rights to Hanmi’s NSCLC asset in all bar a few Asian countries. At that time, Boehringer was looking to hustle the drug to an FDA approval by 2017, a scenario that would have positioned it alongside Giotrif and Vargatef in the company’s assault on the indication.
Boehringer’s abandonment of that plan triggered an 18% drop in the share price of Hanmi, which just 24 hours earlier was celebrating striking a $910 million pact with Genentech.