As US review of Eli Lilly-partnered PD-1 gets underway, Innovent touts another frontline win in China
When Eli Lilly inked a $1 billion-plus deal to grab ex-China commercialization rights for Innovent’s PD-1 Tyvyt (sintilimab), the partners hailed the “clinical profile” of the drug they co-developed and vowed to keep exploring its potential across tumor types.
One year later, Tyvyt has notched another big win on its home turf.
Suzhou-based Innovent says at the interim analysis, the drug hit the primary endpoint of overall survival in ORIENT-16, a Phase III clinical trial for unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. Specifically, it pits a combination of the PD-1 inhibitor and chemotherapy (oxaliplatin and capecitabine) against chemo alone.
The exact OS numbers are being held back for a medical meeting, although Innovent suggests that the results will support a supplemental NDA with the National Medical Products Administration.
“ORIENT-16 is the first Phase 3 clinical trial in China to demonstrate an anti-PD-1 antibody in combination with chemotherapy significantly prolonged overall survival in the first-line treatment of advanced gastric cancer,” said Jianming Xu, the trial’s principal investigator and a professor at the Fifth Medical Center of People’s Liberation Army General Hospital.
He noted that nearly half of all gastric cancer cases — already one of the most common tumor types globally — are diagnosed in China.
In the US, Bristol Myers Squibb has touted positive results with Opdivo in the same setting, while Merck’s Keytruda is approved together with Herceptin and chemo specifically for HER2-positive gastric or GEJ adenocarcinoma.
With the new trial, Tyvyt has now shown effect as a frontline therapy for five major types of cancer, added Zhou Hui, Innovent’s SVP of clinical development: nonsquamous non-small cell lung cancer, squamous non-small cell lung cancer, hepatocellular carcinoma, esophageal squamous cell carcinoma, as well as gastric cancer.
Together with Lilly, which paid $200 million upfront to commercialize the drug in the US and other markets, it has recently filed for its first FDA approval in nonsquamous NSCLC.