- Hanmi Pharm Co. Ltd. is shelving its lung cancer drug Olita because of the more advantageous position a rival therapy holds in the market, The Korean Herald reports.
- South Korean regulators OK'd Olita in May 2016, with the caveat that Hanmi would later have to submit data from late-stage testing. But safety concerns and fizzled partnerships have hamstrung the drug since its approval. On top of that, a similar treatment, AstraZeneca plc's Tagrisso, has been gaining ground in the lung cancer market.
- "We found it difficult to find participants for our clinical studies because there is a medication that has already completed global phase 3 trials and is covered by insurance,” Hanmi said, referring to Tagrisso, in a statement to The Korean Herald.
The outlook for Olita (olmutinib) went from good to grave in less than three years.
In the summer of 2015, German pharma Boehringer Ingelheim GmbH dropped $50 million upfront and put another $680 million in milestone payments on the line to license the drug. Later that year, Hanmi found another licensee for the candidate in Zai Labs Ltd. Financials weren't disclosed, but China-based Zai clearly thought Olita had potential in treating non-small cell lung cancer (NSCLC).
"NSCLC is a huge unmet need in China with the world’s largest patient population. Our collaboration with Hanmi is aimed at bringing this late stage and potentially revolutionary drug quickly to the Chinese patients," Zai CEO Samantha Du said in a November 2015 statement.
About six months after the Zai deal, Olita gained approval in South Korea for patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) NSCLC patients who were T790M mutation-positive and had already received treatment with an EGFR tyrosine kinase inhibitor. Celebrations were short-lived, however.
Boehringer handed back rights to the drug in September 2016, explaining the decision was due to a "re-evaluation of all available clinical data on olmutinib and recent treatment advances made in the treatment of EGFR mutation-positive lung cancer."
The move was made more clear when reports surfaced that Olita treatment had led to two cases of severe skin reactions. One of those patients died, and Hanmi faced criticism from South Korean regulators for dragging its feet in reporting the death.
Compounding those issues, AstraZeneca's Tagrisso (osimertinib) carries the same indication as Olita and has experienced rapid growth — in turn effectively shutting out Olita. The drug raked in close to $1 billion in 2017, and was available in more than 60 countries by the end of the year.
"Although Hanmi was a step ahead in developing Olita in the early stages, the company struggled in the face of a competition against a foreign pharmaceutical giant’s R&D investment and speed in development," the Hanmi official said to The Korea Herald.
Ironically, the reports on Olita surfaced just as AstraZeneca released more positive data from the Phase 3 FLAURA trial, which evaluated Tagrisso as a first-line therapy for locally advanced or metastatic EGFR mutation-positive NSCLC. According to a Friday release, fewer patients receiving first-line Tagrisso discontinued treatment versus those in a comparator arm. Patients in the experimental group also went a median seven months longer before discontinuing EGFR-TKI therapy than comparator arm patients.