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Innovent Gains NMPA Nod for Byvasda Combination in Unresectable HCC


Innovent Biologics said based on success of ORIENT-32, China's National Medical Products Administration (NMPA) has approved sintilimab in combination with bevacizumab biosimilar (Byvasda) in front-line unresectable hepatocellular carcinoma.

Innovent Biologics, said the National Medical Products Administration of China has approved the use of its sintilimab programmed death–1 (PD-1) inhibitor (Tyvyt) in combination with the bevacizumab biosimilar Byvasda as first-line treatment for patients with advanced or unresectable hepatocellular carcinoma (HCC).

The company said this marks the first regulatory approval of a PD-1–inhibitor combination therapy for HCC in the front line. Via the binding of PD-1 proteins on immune cells to the PD ligand 1 (PD-L1) expressed on tumor cells, the immune reaction to cancer cells is “switched off.” PD-1 inhibitors help to prevent this switching off from happening, allowing immune cells to destroy tumor cells.

Liver cancer is the third leading cause of cancer death globally, and China accounts for over 50% of all new cases and deaths worldwide. The disease is a serious threat to the life and health of Chinese people and a heavy burden on society and families, with hepatocellular carcinoma accounting for 85% to 90% of all liver cancer.

Approval was based on findings from ORIENT-32, a randomized, open-label phase 3 trial of frontline Tyvyt in combination with Byvasda vs sorafenib, a kinase inhibitor that suppresses tumor growth, in patients with hepatitis B virus–related, unresectable HCC.

Patients in the combination arm had significantly longer progression-free survival vs patients in the sorafenib group (4.6 months vs 2.8 months, respectively; HR, 0.56; 95% CI, 0.46-0.70; P < .0001). The overall survival for the combination was not reached at data cutoff vs 10.4 months for the sorafenib group (HR, 0.57; 95% CI, 0.43-0.75; P < .0001), according to published findings.

“In China, liver cancer is the second most common cause of cancer-related death and ranks fourth in terms of incidence with a 5-year survival rate of only 10%,” said Fan Jia, MD, of Zhongshan Hospital of Fudan University, Shanghai, China. He served as lead author on ORIENT-32.

Within the subset of liver cancer, HCC accounts for 85% to 90% of incidence, according to Yongjun Liu, president of Innovent.

He noted that patients with HCC do not respond well to chemotherapy or targeted therapy, creating a need for more powerful treatment options such as immunotherapy (PD-1 inhibitors). “ORIENT-32 has demonstrated that sintilimab plus bevacizumab can extend the overall survival and progression-free survival in this patient population and bring significant clinical benefits,” Jia said.

For further details on the positive findings reported from ORIENT-32, click here.

Innovent Biologics is based in Suzhou, China, and has offices in San Francisco, California.

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