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 Ipsen to Present New Data at 13th Annual Conference of the International Liver Cancer Association (ILCA 2019)

Nachrichtenquelle: Business Wire (engl.)
20.09.2019, 18:30  |  326   |   |   

Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY) today presents results from the matching-adjusted indirect comparison (MAIC) of cabozantinib (Cabometyx) versus regorafenib (Stivarga) for the second-line treatment (2L) of patients with advanced hepatocellular carcinoma (aHCC) who received sorafenib as the only prior systemic therapy. Using data from the Phase III CELESTIAL and RESORCE trials, the MAIC showed that cabozantinib offers greater efficacy versus regorafenib.

Using data from the Phase III CELESTIAL and RESORCE trials, the MAIC showed that in the 2L CELESTIAL sub-population who had received sorafenib as the only prior systemic therapy, cabozantinib significantly improved progression-free survival (PFS), with an additional 2.4 months provided vs. regorafenib (5.6 months vs. 3.2 months [95% confidence interval (CI): 4.90-7.26], p<0.05). Median overall survival (OS) was also favorable with cabozantinib (11.4 months vs. 10.8 months), though statistical significance was not met.1

Results from MAIC will be presented by Dr. Katie Kelley, oncologist at the University of California, San Francisco and lead investigator, at the 13th Annual Conference of the International Liver Cancer Association (ILCA 2019) taking place on 20-22 September 2019 in Chicago, USA (poster/abstract #P-021).

In the previously presented randomized, double-blind, Phase III CELESTIAL trial evaluating cabozantinib compared with placebo in previously treated patients with aHCC, in the overall CELESTIAL intent-to-treat population, cabozantinib significantly improved median PFS, with an additional 3.3 months provided vs placebo (5.2 months vs. 1.9 months [95% CI, 4.0 to 5.5], p<0.001) and median OS, with an additional 2.2 months vs placebo (10.2 months vs. 8.0 months [95% confidence interval (CI): 9.1 to 12.0), p=0.005).1

“Hepatocellular carcinoma is a devastating disease with only a few treatment options demonstrating survival benefits and many investigational drugs have failed to meet overall survival endpoints in clinical trials,” said Dr. Kelley. “The MAIC analysis brings further insight into the comparative effectiveness of the key second-line treatments for advanced hepatocellular carcinoma, particularly in relation to important endpoints like progression-free survival. These results may support clinicians in making informed treatment decisions in order to deliver optimal care for their patients.”

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