Hanmi calls time on troubled Tagrisso rival olmutinib

stop sign (knerri61/Pixabay)
Decision has been prompted by trial recruitment issues and a competitive commercial landscape (knerri61/Pixabay)

Hanmi Pharmaceutical’s long and turbulent development of lung cancer drug olmutinib came to an end this week after the company abandoned the program.

The South Korean drugmaker took the decision after struggling to recruit patients into clinical trials and concluding that the third-generation EGFR inhibitor was too far behind Tagrisso (osimertinib), AstraZeneca’s fast-growing rival, to make a commercial success of the drug, according to a Korea Biomedical Review report.

Back in 2015, the olmutinib program was riding high on the back of a promising midstage data in T790M-mutated non-small cell lung cancer (NSCLC) and a $730 million licensing deal with Boehringer Ingelheim. The German company described the drug as a possible best-in-class candidate that it was hoping to pair with Merck & Co’s immuno-oncology blockbuster Keytruda in a combination trial.

Sponsored By Syneos Health

Blazing a Trail to Clinical Trial Diversity: Four-Part Webinar Series from Syneos Health, Featuring Pharma, Clinical Research and Community Health Leaders

This series will identify obstacles that stifle appropriate patient diversity in trials; unpack the organizational overhaul needed; share how sponsors, patients & investigators have come together to overcome hurdles; and explore how policy innovations can move the industry forward.

Just over a year later, Boehringer backed out of the deal after taking another look at the clinical data for the drug and the increasingly crowded EGFR inhibitor market, even though olmutinib had already picked up its first approval—as Olita—in Hanmi’s home market.

Things went from bad to worse last year when the Korean authorities rapped the company for not acting quickly enough to disclose a fatality in a patient treated with the drug who developed life-threatening skin condition Stevens-Johnson syndrome (SJS). All told, the drug was linked to three cases of SJS, two of which proved fatal.

Yet more controversy ensued after Hanmi employees were accused of insider trading relating to the termination of the Boehringer deal, and the Korean firm also lost another partner for olmutinib when Chinese licensee Zai Lab returned rights to the drug.

Meanwhile, olmutinib isn’t the only Hanmi drug to run into trouble of late. Its Eli Lilly-partnered BTK inhibitor LY3337641 failed to hit its objectives in a phase 2 trial in rheumatoid arthritis, leaving the future of the program in other indications under a cloud, while at the end of 2016 a $4.2 billion, three-drug deal with Sanofi for diabetes therapies was trimmed down to two candidates.

Other partnerships with Spectrum for Rolontis (eflapegrastim) and pan-HER drug poziotinib, Johnson & Johnson for diabetes and obesity candidate HM12525A and Roche/Genentech for RAF-targeted cancer drugs currently remain on track.