A cancer combination therapy led and developed by Korea has recently been added to international treatment guidelines for major cancers such as lung and liver cancer. With a homegrown new drug officially recognized as a global standard therapy, market entry and expanded prescriptions are expected to gain full momentum.
On the 10th, HLB said that the combination therapy of the liver cancer drug under development rivoceranib and China's Jiangsu Hengrui Pharmaceuticals' camrelizumab was recently listed in the Barcelona Clinic Liver Cancer (BCLC) guideline as a first-line therapy for patients with advanced liver cancer. It is a measure that has clinicians prioritize recommending it as the first-line therapy for the disease.
In the latest BCLC guideline published in the Journal of Hepatology, the official journal of the European Association for the Study of the Liver (EASL), the HLB–Jiangsu Hengrui combination therapy was included as a first-line standard therapy for patients with advanced liver cancer alongside three existing combination therapies.
The BCLC guideline underpins liver cancer treatment worldwide and is an international standard that presents optimal treatments by comprehensively assessing tumor size and number, liver function, general condition, and metastasis. The U.S. National Comprehensive Cancer Network (NCCN) guideline also uses the BCLC guideline as its basic framework.
The rivoceranib combination therapy was also recommended as a first-line therapy in the hepatocellular carcinoma (HCC) diagnosis and treatment guideline of the European Society for Medical Oncology (ESMO) in March.
The industry expects the successive listings in international guidelines to positively affect approval by the U.S. Food and Drug Administration (FDA). HLB and Jiangsu Hengrui have applied for new drug approval twice with the FDA but were frustrated due to manufacturing facility deficiencies uncovered during Jiangsu Hengrui's on-site inspection. Jiangsu Hengrui has addressed the FDA's cited issues and is preparing for a third attempt.
Han Yong-hae, HLB Group chief technology officer (CTO), said, "We will carefully prepare complete data to proceed with the approval process and do our best to ensure that more patients can enjoy tangible treatment benefits after commercialization."
The combination therapy of Yuhan Corp.'s U.S. FDA-approved lung cancer drug Leclaza (lazertinib) is also expanding its presence in the global lung cancer treatment market.
The combination therapy of Leclaza and amivantamab (Rybrevant) from Janssen, a subsidiary of Johnson & Johnson (J&J), was designated a preferred regimen in the NCCN non-small cell lung cancer (NSCLC) guideline on the 6th (local time).
Until now, the NCCN preferred regimens were only AstraZeneca's Tagrisso (osimertinib) monotherapy and combination therapy. However, according to clinical results presented at the European Lung Cancer Congress (ELCC) in March, the median overall survival (OS) for patients treated with the Leclaza combination therapy exceeded 50 months. That is at least 12 months longer than Tagrisso monotherapy. The Leclaza combination therapy is the first treatment to extend Tagrisso's median OS.
The Leclaza combination therapy has been regarded as a new option for treating non-small cell lung cancer, but prescriptions had not been active in clinical settings due to a lack of recommendations in global guidelines. The industry expects the NCCN designation to trigger full-fledged prescription competition between Leclaza and Tagrisso.
Im Seon-min, a medical oncologist at Yonsei Cancer Center who participated in the Leclaza clinical study, said, "The NCCN designates as preferred regimens those therapies that have demonstrated improvement in OS, the most important indicator in clinical practice," adding, "Accordingly, Tagrisso monotherapy is expected to gradually drop in ranking in the guideline."