Elevar's Landmark Study Offers New Hope for Liver Cancer Patients

FORT LEE, NJ – December 03, 2025 – The global fight against liver cancer has gained a powerful new contender, as final results from a pivotal Phase 3 study have delivered one of the most significant survival advantages seen in years for patients with the most common and aggressive form of the disease. Elevar Therapeutics announced that the final analysis of its CARES-310 study was published in the prestigious medical journal The Lancet Oncology, providing robust validation for its combination therapy.

The study evaluated rivoceranib, an oral drug that restricts tumor blood supply, in combination with camrelizumab, an immunotherapy that unleashes the body's own immune system against cancer cells. For patients with unresectable hepatocellular carcinoma (uHCC), a form of liver cancer that cannot be surgically removed, the combination therapy demonstrated a clinically meaningful improvement in survival compared to a long-standing standard of care. This milestone publication sets the stage for the company's planned resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in January 2026, moving a promising treatment one step closer to the patients who desperately need it.

A New Standard of Care on the Horizon

The data published in The Lancet Oncology details a remarkable leap forward. In the international trial involving 543 patients, those receiving the rivoceranib and camrelizumab combination achieved a median overall survival of 23.8 months. This represents a substantial 8.6-month extension of life compared to the 15.2 months recorded for patients receiving sorafenib, a therapy that has been a benchmark in first-line treatment for over a decade. The hazard ratio of 0.64 indicates a 36% reduction in the risk of death for patients on the combination therapy.

For patients and families grappling with a uHCC diagnosis, this extension is more than just a statistic. Hepatocellular carcinoma carries a grim prognosis, with more than 800,000 new diagnoses and over 700,000 deaths worldwide each year. It often develops in individuals with chronic liver diseases and presents limited treatment options once it reaches an advanced stage. The results from the CARES-310 study offer a tangible hope for more time and a potential shift in the global standard of care.

"Having our Phase 3 study final analysis published in a prestigious journal such as The Lancet Oncology is momentous for Elevar Therapeutics and, even more so, for the global liver cancer patient community,” said Bryan Kim, chief executive officer of Elevar, in the company's official announcement. “The data clearly showed the potential of our combination treatment of camrelizumab and rivoceranib, as it significantly improved survival compared to the standard treatment option."

While the efficacy results are compelling, the treatment's safety profile provides a complete clinical picture. The combination therapy was deemed to have a manageable safety profile, though it was associated with a higher incidence of severe, or Grade 3/4, treatment-related adverse events compared to sorafenib (81% vs. 52%). The most common serious side effects included hypertension and elevated liver enzymes. While these require careful clinical management, the significant survival benefit suggests that for many patients, the trade-off may be acceptable in the context of such a life-threatening disease.

Navigating the Path to FDA Approval

The publication serves as more than just academic validation; it is a cornerstone of Elevar's regulatory and commercial strategy. The company's plan to resubmit its NDA in January 2026 points to a previous, unsuccessful interaction with the FDA. Public records indicate a prior FDA decision date for rivoceranib was set for May 2024. While the specifics of the FDA's initial feedback are not public, arming the resubmission with this definitive, peer-reviewed final analysis from a large-scale international study significantly strengthens the case for approval.

If successful, the approval would be a monumental achievement for Elevar and its majority-owned parent, South Korean conglomerate HLB Co., Ltd. It would mark a major entry into the lucrative U.S. oncology market and could make rivoceranib the first novel anti-cancer drug developed by a Korean-affiliated company to secure FDA approval, a landmark moment for the nation's burgeoning biotech industry.

The competitive landscape for first-line uHCC treatment has evolved rapidly. While sorafenib was the comparator in the CARES-310 trial, the current market standard has shifted toward other combination therapies, notably atezolizumab plus bevacizumab. However, Elevar's combination of an oral TKI with an immune checkpoint inhibitor offers a distinct mechanism and a convenient oral component, positioning it as a strong future competitor. The CARES-310 study is the first positive international Phase 3 trial to successfully combine a PD-1 inhibitor with an oral small-molecule TKI, carving out a unique space in the treatment paradigm.

The Science of Synergy: Targeting Cancer on Multiple Fronts

The success of the CARES-310 study is a prime example of a dominant trend in modern oncology: hitting cancer with a one-two punch. Instead of relying on a single mechanism, combination therapies target the disease from multiple angles simultaneously.

Rivoceranib is a potent tyrosine kinase inhibitor (TKI) that blocks a protein called VEGFR-2, which is critical for angiogenesis—the process tumors use to grow new blood vessels to feed themselves. By cutting off this supply line, rivoceranib effectively starves the tumor. Meanwhile, camrelizumab is a PD-1 inhibitor, a class of immunotherapy drugs that have revolutionized cancer care. It works by blocking a protein on immune cells that cancer often exploits to hide. By inhibiting PD-1, camrelizumab takes the brakes off the immune system, allowing it to recognize and attack cancer cells.

The synergy between these two approaches is powerful. By restricting blood flow, the TKI may create an environment within the tumor that is more susceptible to an immune attack, enhancing the effect of the PD-1 inhibitor. This multi-pronged assault has proven more effective than targeting a single pathway.

The global collaboration behind this therapy underscores the modern drug development process. Rivoceranib is Elevar's asset, while camrelizumab was developed by Chinese pharmaceutical giant Jiangsu Hengrui Pharmaceuticals. In October 2023, Elevar licensed the rights to commercialize camrelizumab outside of Greater China and Korea, enabling the two drugs to be paired as a combination therapy for global markets. Both drugs already have a track record of approval in China for various cancers, including for uHCC, providing early confidence in the combination's potential long before the final CARES-310 results were known. With the final data now published for the world to see, the focus shifts from clinical validation to the final regulatory hurdles standing between this promising therapy and the patients awaiting a new option.