Top-line findings have been offered right now on the annual European Society for Medical Oncology (ESMO) Congress
- This is the primary optimistic pivotal trial to point out survival advantages with a PD-1 inhibitor plus an anti-angiogenic TKI for uHCC
- Sorafenib is an ordinary first-line therapy for uHCC
PARIS, Sept. 10, 2022 (GLOBE NEWSWIRE) — Elevar Therapeutics, Inc., a completely built-in biopharmaceutical firm devoted to elevating therapy experiences and outcomes for sufferers who’ve restricted or insufficient therapeutic choices, right now introduced top-line outcomes from the Phase 3 research of its drug candidate rivoceranib mixed with camrelizumab versus sorafenib as a first-line remedy for unresectable hepatocellular carcinoma (uHCC). Camrelizumab plus rivoceranib considerably extended general survival (OS) and progression-free survival (PFS), and improved general response fee (ORR) versus sorafenib, an ordinary first-line therapy for uHCC. The findings have been offered right now throughout the annual Congress of the European Society for Medical Oncology (ESMO) in Paris.
“Camrelizumab (C) plus rivoceranib (R) vs. sorafenib (S) as first-line therapy for unresectable hepatocellular carcinoma (uHCC): a randomized, phase 3 trial,” was shared as a proffered paper presentation at ESMO. A pre-recorded video of Elevar’s presentation is now out there for viewing.
This international, randomized, open-label trial (NCT03764293) included 543 sufferers (ITT inhabitants), 17.3% of whom have been non-Asian. The research started in June 2019, reaching its main endpoint in April 2022. Top-line knowledge included:
- Median OS for camrelizumab+rivoceranib was 22.1 mos. [95% CI 19.1-27.2] vs. 15.2 mos. [13.0-18.5]; hazard ratio (HR) 0.62 [95% CI 0.49-0.80]; 1-sided p<0.0001,
- Median PFS for camrelizumab+rivoceranib was 5.6 mos. [95% CI 5.5-6.3] vs. 3.7 mos. [2.8-3.7]; HR 0.52 [95% CI 0.41-0.65]); 1-sided p<0.0001, and
- Confirmed ORR for camrelizumab+rivoceranib was 25.4% (95% CI 20.3-31.0), in comparison with 5.9% (3.4-9.4) for sorafenib.
“The efficacy results were generally consistent across all subgroups and with those reported in the overall ITT population, suggesting the combination of rivoceranib and camrelizumab confers a benefit in a global unresectable HCC population,” mentioned Saeho Chong, chief govt officer of Elevar.
In China, greater than two-thirds of HCC instances are related to hepatitis B virus (HBV) an infection, and roughly 10% of instances are related to hepatitis C virus (HCV). In the U.S., roughly 10% of HCC instances are estimated to be related to HBV and 60% are estimated to be on account of HCV (deMartel, 2015).
“In our uHCC trial, there was an overall consistent trend of prolonged PFS for patients in the camrelizumab plus rivoceranib arm compared to those in the sorafenib arm, irrespective of geographical region (Asian vs. non-Asian) or etiology (HBV vs. HCV vs. non-viral),” mentioned Jan M. Van Tornout, M.D., MSc., chief medical officer of Elevar. “Specifically, the combination of camrelizumab and rivoceranib demonstrated efficacy among those with HCV-based etiology, which comprises the majority of U.S. HCC cases1.”
The following knowledge from the trial compares OS HR and PFS HR in Asian vs. non-Asian populations and in sufferers with totally different virus-based etiology:
- OS HR in Asian 0.66 (95% CI 0.51, 0.86) vs. non-Asian 0.55 (0.29, 1.02),
- OS HR in HBV 0.66 (0.5, 0.87) vs. HCV 0.45 (0.18, 1.16) vs. non-viral 0.71 (0.37, 1.36),
- PFS HR in Asian 0.55 (95% CI 0.45, 0.70) vs. non-Asian 0.56 (0.30, 1.07), and
- PFS HR in HBV 0.53 (0.41, 0.68) vs. HCV 0.56 (0.22, 1.45) vs. non-viral 0.65 (0.36, 1.20)
“HCC is the most common type of liver cancer, which despite advances in surgery, transplantation and approval of systemic therapies, still conveys a poor prognosis and survival rate,” mentioned Ahmed Omar Kaseb, M.D., professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center in Houston. “The combination of camrelizumab and rivoceranib shows potential to address what is clearly an unmet medical need for HCC patients globally.”
Elevar additionally introduced on the American Society of Clinical Oncology (ASCO) annual assembly in June 2022 that in its Phase 2 medical trial (Study RM-202) of rivoceranib monotherapy in sufferers with progressive recurrent or metastatic adenoid cystic carcinoma (R/M ACC), rivoceranib demonstrated medical effectiveness, as indicated by considerably lowered tumor development throughout the six months after rivoceranib therapy in comparison with the tumor development throughout the six months previous to rivoceranib therapy.
“Based on the positive results of the combination study, Elevar plans to work closely with the U.S. Food & Drug Administration for submission of a New Drug Application (NDA) for rivoceranib in combination with camrelizumab as a treatment option for HCC,” mentioned Chong. “In addition, Elevar anticipates submission of an NDA to the U.S. Food & Drug Administration for rivoceranib as a treatment option for ACC by the end of 2022.”
1. Yoshizawa H. Hepatocellular carcinoma related to hepatitis C virus an infection in Japan: Projection to different nations within the foreseeable future. Oncology. 2002;62(Suppl 1):8–17. [PubMed: 11868791]; El-Serag HB, Rudolph KL. Hepatocellular carcinoma: Epidemiology and molecular carcinogenesis. Gastroenterology. 2007;132:2557–76. [PubMed: 17570226]
About Hepatocellular Carcinoma (HCC)
HCC is the most typical kind of main liver most cancers. It most regularly happens in individuals with continual liver ailments, similar to cirrhosis attributable to hepatitis B or hepatitis C an infection. HCC usually has a poor prognosis and an absence of therapy choices and is due to this fact a situation with an pressing medical want.
About Camrelizumab
Camrelizumab (SHR-1210) is a humanized monoclonal antibody concentrating on the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic technique displaying success in all kinds of strong and hematological cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in additional than 5,000 sufferers. Currently, 50 medical trials are underway in a broad vary of tumors (together with liver most cancers, lung most cancers, gastric most cancers, and breast most cancers et al.) and therapy settings.
Camrelizumab, underneath the model identify AiRuiKa®, is at the moment accepted for eight indications in China, together with monotherapy for the therapy of HCC (second-line), relapsed/refractory basic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or additional) and together with chemotherapy for the therapy of non-small cell lung most cancers (non-squamous and squamous), esophageal squamous cell carcinoma and nasopharyngeal carcinoma within the first-line setting. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for superior HCC in April 2021.
About Rivoceranib
Rivoceranib is the primary small-molecule tyrosine kinase inhibitor (TKI) accepted in gastric most cancers in China (November 2014). Rivoceranib is a extremely potent inhibitor of vascular endothelial development issue receptor 2 (VEGFR-2), a main pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated strategy to restrict tumor development and illness development. Rivoceranib is co-developed by Hengrui Pharma in China and by Elevar Therapeutics, Inc. globally (excluding China). It has been studied in additional than 6,000 sufferers worldwide and was effectively tolerated in medical trials with a comparable security profile to different TKIs and VEGF inhibitors. Rivoceranib is at the moment being studied as a monotherapy and together with chemotherapy and immunotherapy in varied strong tumor indications. Clinical research are ongoing in a number of strong tumor varieties together with gastric most cancers (as a monotherapy and together with paclitaxel), hepatocellular carcinoma (HCC) (together with camrelizumab), adenoid cystic carcinoma (as monotherapy) and colorectal most cancers (together with Lonsurf®). Orphan drug designations have been granted in gastric most cancers (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in HCC (U.S.). Elevar holds the worldwide rights (excluding China) and has partnered for the event and advertising and marketing of rivoceranib with HLB-LS in South Korea. Rivoceranib, underneath the identify apatinib, is at the moment accepted in China for superior gastric most cancers and in second-line superior HCC by the Chinese-territory license-holder, Hengrui Pharma, underneath the model identify Aitan®.
About Elevar Therapeutics
Elevar Therapeutics, Inc. is a quickly rising, absolutely built-in biopharmaceutical firm constructed on the promise of elevating therapy experiences and outcomes for sufferers who’ve restricted or insufficient therapeutic choices. Elevar’s lead proprietary drug candidates embody rivoceranib and paclitaxel micellar (Apealea®). Rivoceranib, underneath the identify apatinib in China, was developed by Hengrui Pharma in China and accepted in China as a single agent for therapy of gastric most cancers in 2014 and second-line superior HCC in 2020. It has been granted orphan drug designation within the U.S., Europe and South Korea and has been clinically examined in additional than 1,000 sufferers worldwide in quite a few most cancers indications. Apealea® is a non-Cremophor EL primarily based formulation of paclitaxel that acquired advertising and marketing authorization by the European Commission in November 2018, making it Europe’s first non-Cremophor EL formulation of paclitaxel accepted to be used in ovarian most cancers. Elevar has places of work in Utah, California, Ireland and South Korea. Additional data is out there at ElevarTherapeutics.com.
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