Eisai announced in February that in a phase I treatment of advanced hepatocellular carcinoma phase III study (Study 304) with sorafenib as a control, the overall survival of the levabinib-treated group was not inferior to that of Solafi. Sorafenib, reached a non-inferior end point. Although no specific data was released at the time, it still caused a sensation.
Sorafenib was first approved by the FDA for the treatment of advanced renal cell carcinoma on December 12, 2005. It was approved for the treatment of advanced hepatocellular carcinoma on 11/17/2007. It is the first clear evidence to improve the survival of patients with advanced liver cancer. The systemic treatment drug is the first-line clinical standard for patients with hepatocellular carcinoma. Levantinib achieved comparable survival data for sorafenib in the study, and people are looking forward to its prospects.
On June 4th, Eisai announced the study of the specific data of Study 304 at the ASCO 2017 conference, which once again attracted a lot of surprise.
The median overall survival (OS) was 13.6 months in the levabinib-treated group and 12.3 months in the sorafenib group. Levaltinib was superior to sorafenib and achieved non-inferiority. The main end point. At the secondary endpoint of median progression-free survival, levabinib was twice as high as sorafenib (7.4 vs 3.7 months). At the secondary endpoint of median disease progression time (mTTP) and objective response rate, levovirinib was also significantly better than sorafenib (8.9 vs 3.7 months, 24% vs 9%).
In terms of safety, adverse reactions in the lovretini treatment group included hypertension, diarrhea, loss of appetite, weight loss and fatigue, consistent with known side effects.
Based on the data from the Study 304 study, Eisai plans to submit a listing application for hepatocellular carcinoma indications to Japanese, US and EU regulators in the first half of fiscal 2017 (before the end of September 2017) in the fiscal year 2017 (end of March 2018) Previous) Submit the relevant application to CFDA. Levartini is expected to be the second targeted drug to receive first-line treatment for hepatocellular carcinoma after sorafenib.
Liver cancer is the second leading cause of cancer death in the world, with approximately 750,000 deaths from liver cancer each year. There are about 780,000 newly diagnosed liver cancer patients every year in the world, 80% of which are newly distributed in Asian countries such as China and Japan. Hepatocellular carcinoma accounts for about 85% to 90% of primary liver cancer. Early hepatocellular carcinoma has many treatments, including surgery, radiofrequency ablation, ethanol injection, and chemoembolization. However, for unresectable hepatocellular carcinoma, treatment options are very limited, the prognosis is extremely poor, and medical needs are far from being met.
The development of targeted drugs for liver cancer is slow. On April 27, 2017, Bayer's Stivarga (Rigofini) was approved for new indications for second-line treatment of sorafenib-treated hepatocellular carcinoma, becoming the first new liver cancer drug approved by the FDA in the past 10 years. With the first-line administration of sorafenib and the second-line medication of Regofenib, Bayer is "covering the sky" in the hepatocellular carcinoma targeted drug market.
Levartini has been approved by the FDA for second-line treatment of renal cell carcinoma on May 5, 2016. The approval of first-line treatment for hepatocellular carcinoma is also a very probable event. After the market, it will undoubtedly become the "hard enemy" of Sorafenib. However, in addition to levastatin, Bayer is also about to face the impact of hot tumor immunotherapy drugs. The supplemental application of PD-1 monoclonal antibody Opdivo for the treatment of hepatocellular carcinoma with disease progression after sorafenib treatment has been accepted and prioritized by the FDA. Phase III data for Opdivo's first-line treatment of hepatocellular carcinoma is also coming soon.
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