Junshi, Coherus gun for major PD-(L)1 market with PhIII NSCLC results
As a slate of made-in-China checkpoint inhibitors arrive on the scene, China-based drugmakers have shown time and again that they’re not content with just the Chinese market or niches of the American market. Rather, they are more than eager to follow the sprawling roadmap that leaders like Merck and Bristol Myers Squibb have offered — and dive right into large cancer indications.
For the latest example, look no further than Shanghai Junshi — the first biotech to steer a homegrown PD-(L)1 toward approval from China’s NMPA.
Junshi touted positive results from a Phase III lung cancer trial late Wednesday, as toripalimab (Tuoyi in China) beat placebo as a first-line treatment when combined with chemotherapy. Among 465 advanced non-small cell lung cancer patients who have never received therapy (both squamous and nonsquamous), investigators observed a “significant improvement in progression-free survival at the interim analysis.”
Together with partners at Coherus, Junshi said it plans to meet with the FDA — where it’s already racked up breakthrough designations for two different types of nasopharyngeal carcinoma. Coherus wagered $150 million cash for US rights to the drug.
After years of speculation from analysts and commentators that the new wave of PD-(L)1 inhibitors from China will commoditize the class, there’s little sign that prices in the US will come down any time soon. But that doesn’t mean Chinese biotechs aren’t gearing up to mount attacks on all fronts — just a few days ago, Eli Lilly-partnered Innovent unveiled a fresh data set for gastric or gastroesophageal junction adenocarcinoma.
In Tuoyi’s NSCLC trial, Junshi said the hazard ratio was 0.58 (p=0.0001), with median PFS of 8.3 months versus 5.6 months for those on placebo.
At the one-year cutoff, the rates of patients who lived without their disease progressing were 32.6% and 13.1% for the toripalimab and placebo arms, respectively.
NSCLC, through all lines of treatment, has long been considered a hugely needed, multibillion-dollar opportunity.
“With an excellent clinical profile being established across multiple tumor types, we expect to pursue registration for toripalimab for a broad array of indications in China, the United States and other markets,” said Junshi CMO Patricia Keegan.
Junshi has lined up pivotal studies across esophageal, lung, liver, breast, kidney, bladder, stomach and skin cancers.
Social image: Li Ning, Junshi CEO