BARCELONA — Merck and Daiichi Sankyo have passed a Phase 3 with the lead antibody-drug conjugate from the megadeal they disclosed at last year’s European Society for Medical Oncology confab.
The new topline result, which was released Tuesday morning with no hard data, came out as this year’s ESMO wrapped up, and a few months after the drug was rejected by the FDA over manufacturing concerns.
The duo said its HER3 ADC, named patritumab deruxtecan, helped keep patients alive longer without disease progression in a study code-named HERTHENA-Lung02.
The companies said it was a statistically significant result compared to doublet chemotherapy, but they didn’t disclose how wide the margin was. The companies “plan to initiate regulatory discussions” based on the results announced Tuesday, a Merck spokesperson confirmed to Endpoints News.
The trial included patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer who had previously tried an EGFR tyrosine kinase inhibitor.
“Unfortunately, today, chemotherapy is not a great option for these patients. They need more, and so we’re super-happy about these results,” Ken Keller, global head of Daiichi’s oncology unit, said on an Endpoints News webinar Tuesday morning.
The companies had sought approval in the third-line setting based on a different trial, dubbed HERTHENA-Lung01, but the ADC was rejected this summer because of inspection findings at a third-party manufacturer.
“We’ve been working with the third party [manufacturer] to help them make the corrections. We’re confident that it’s resolvable, but we haven’t announced the timing of that,” Keller said on the webinar, which aired after the topline result was disclosed. “My hope is yes, but we’ve got to work through a few things still.”
The companies said HERTHENA-Lung02 data on the secondary endpoint of overall survival were immature and that they’ll continue the study to further analyze that measure. Overall survival has become an increasingly important piece for the FDA.
Merck and Daiichi said there were two deaths from interstitial lung disease, but that the majority of the ILD events were grades 1 and 2.
The companies are working on two additional ADCs together and recently teamed up on a T cell engager that Merck got by way of its acquisition of Harpoon Therapeutics. Merck chief medical officer Eliav Barr told Endpoints News on the sidelines of ESMO this weekend that he hopes they can “revolutionize” small cell lung cancer with some of those therapies.
Editor’s note: This story was updated to include comments from Daiichi Sankyo head of global oncology Ken Keller.