South Korean pharma Yuhan has licensed its lung cancer drug lazertinib to Janssen Biotech for $50 million upfront and another $1.2 billion in milestones.
The drug, billed as a third-generation EGFR tyrosine kinase inhibitor, has already generated positive results in a phase 1/2 non-small cell lung cancer (NSCLC) trial reported at this year’s ASCO meeting.
Lazertinib is however a long way behind Tagrisso (osimertinib), AstraZeneca’s fast-growing rival in the third-generation category, which has already become established as a second-line treatment for EGFR-mutated NSCLC and this year has claimed its first approvals as a first-line option.
It’s a much better outcome for Yuhan’s drug than a similar EGFR program pursued by fellow South Korean drugmaker Hanmi Pharma, which was abandoned earlier this year after the company decided it was too far behind Tagrisso to be a commercial success.
At ASCO, early data showed a 66% overall response rate with lazertinib in patients with EGFR-positive NSCLC that had progressed on older EGFR inhibitors. At the dose that will be brought forward into the next trial stage (240 mg once daily), the response rate rose to 86%.
Yuhan has made much of lazertinib’s ability to cross the blood-brain barrier and has preliminary evidence that it is effective in treating patients whose primary lung cancers have spread to the brain, with a 55% response rate for intracranial tumors in the trial. The lead investigator in the study, Byoung Chul Cho, M.D., Ph.D., of Yonsei Cancer Center in Seoul, told eCancer at ASCO that preclinical studies suggest lazertinib is better at penetrating the central nervous system than AZ’s drug. Brain metastases are thought to affect around one in four EGFR-mutated NSCLC patients at the time of diagnosis.
In a statement, Yuhan said that its clinical results, and a low rate of serious adverse events, “indicate that lazertinib may offer the possibility of a wider therapeutic index, making it a potential best-in-class candidate as a combination regimen.”
Johnson & Johnson unit Janssen is planning to start new trials of lazertinib with Yuhan next year, as a monotherapy as well as in combination with other drugs, according to the two companies, which say they hope to develop it as a rival to Tagrisso in first-line patients. The licensing deal comes just a few weeks after J&J abandoned a late-stage program focused on telomerase inhibitor imetelstat, partnered with Geron, knocking a hole in the company’s midstage oncology pipeline.