Eli Lilly and Innovent have released the detailed results from a phase 3 study of their PD-L1 inhibitor Tyvyt in combination with Alimta in first-line non-small cell lung cancer (NSCLC) at the virtual IASLC World Conference on Lung Cancer (WCLC).
In the 397-patient ORIENT-11 trial, Tyvyt (sintilimab) and Alimta (pemetrexed) were administered in combination with platinum chemotherapy as a first-line treatment for advanced or recurrent NSCLC without EGFR or ALK mutations.
The treatment significantly extended the time to tumour progression or death in this patient population, with a media progression-free survival of 8.9 months compared to five months for the placebo arm.
Although median overall survival (OS) was not reached in both groups, OS showed an improvement favouring the Tyvyt combination. The objective response rate improved from 29.8% to 51.9%, with the Tyvyt treatment demonstrating a shorter response time.
“Being able to present the results of ORIENT-11 at the WCLC 2020 Presidential Symposium is a major recognition,” said Li Wang, senior vice president of Lilly China and head of Lilly China Drug Development and Medical Affair Centre.
“With these encouraging results of ORIENT-11, Tyvyt may soon be able to expand its indication to the first-line treatment of non-squamous NSCLC,” he added.
Tyvyt’s major rival is Merck & Co’s Keytruda (pembrolizumab), which holds approvals across a range of NSCLC indications. It hold three approvals for NSCLC in China, Innovent’s home market.
Keytruda has quickly been established as the new standard of care in NSCLC, after data from the KEYNOTE-189 study found that the drug, plus chemotherapy, reduced the risk of death by 51% in first-line NSCLC patients.
Lung cancer is the leading cause of cancer deaths in China, with more than 787,000 new cases diagnosed in the country each year and more than 631,000 deaths caused by the disease. NSCLC is the most common type of lung cancer, accounting for 85% of all new cases.
China’s National Medical Products Administration (NMPA) has already accepted the supplemental new drug application for Tyvyt in first-line NSCLC, setting it up for a market clash with Keytruda in the near future.
Tyvyt has also been approved in China for the treatment of relapsed or refractory classical Hodgkin’s lymphoma (cHL).