Innovent and Lilly win second China OK for Tyvyt in frontline NSCLC, ramping up pressure on king Keytruda
Innovent Biologics and its partners at Eli Lilly have notched another arrow in their quiver in their bid to take down Merck’s Keytruda.
Chinese regulators granted a prominent new approval for the pair’s Tyvyt on Wednesday, indicating the drug for first-line treatment of nonsquamous non-small cell lung cancer in combination with pemetrexed and platinum chemo. It’s the second approval in the country for the Chinese powerhouse and American Big Pharma, after Tyvyt was OK’ed in 2018 for relapsed or refractory classical Hodgkin’s lymphoma after two lines of chemotherapy.
Tyvyt is looking to break into a space where Keytruda has long dominated, having been already approved in both spaces. In the third quarter of 2020 alone, Keytruda tallied $3.7 billion in global sales.
Innovent’s green light comes on the basis of a randomized, double-blind, Phase III trial with 397 NSCLC patients. Individuals received either Tyvyt or a placebo, plus Alimta and platinum chemotherapy as a first-line treatment. Those on Tyvyt saw a median progression-free survival of 8.9 months, as opposed to just five months on the placebo.
The data package also included overall survival figures, which had not been ready as of the interim analysis reported back in August. After an extended follow-up, the median OS of the drug arm was still not reached, while the placebo group saw a median OS of 16 months. That notched a p-value of p=0.0025.
Lung cancer has the highest incidence and mortality rates among all tumor types, Innovent VP of medical science Hui Zhou said in a statement.
Innovent has had high expectations ever since its founding back in 2011, with the goal to lead the first biosimilar wave in China. The company partnered with Lilly in 2015 to develop and commercialize Tyvyt, and raised a then-record $260 million Series D round in 2016.
It reached unicorn status during its 2018 IPO that reaped it another $421 million in fundraising. And a few months after its debut, Innovent became the first drugmaker to get a homegrown Chinese checkpoint inhibitor across the finish line in the country when Tyvyt gained approval in Hodgkin’s lymphoma.
Then, this past June, Innovent picked up another partnership with a big-time pharma player — Roche. Innovent is researching bispecific antibodies and cell therapies for use in hematological and solid cancers, with Roche on the hook for nearly $2 billion in milestones if it exercises all its options.
Innovent is facing stiff competition from other Chinese companies, however. Last September, Junshi declared a Phase III success for its lead drug toripalimab in recurrent or metastatic forms of nasopharyngeal carcinoma, data that earned the program breakthrough status. And just this past Monday, Coherus BioSciences dropped $150 million upfront for the rights to the drug, with Junshi handing back $50 million to invest in the company the next day.
Innovent CEO Michael Yu (Photographer: Anthony Kwan/Bloomberg via Getty Images)