Chinese pharmaceutical company Hengrui Medicine announced the progress of the development of combination therapy for lung cancer for Rivoceranib (Apatinib, brand name Aitan) through a notice.
1. Approval of Phase 3 clinical trial for lung cancer
Hengrui Medicine is approved for the phase 3 trial for 1st line treatment of non-small cell lung cancer in China.
(1) Rivoceranib + Gefitinib combination
(2) Rivoceranib + Camrelizumab (SHR-1210) combination
2. Lung cancer clinical trial results
Rivoceranib's clinical trial for non-small cell lung cancer was conducted with various degrees and combination therapies.
DCR: Disease Control Rate
ORR: Objective Response Rate
3. Other lung cancer clinical trial results
The results of the clinical trial of Rivoceranib's lung cancer was annually published at the World Conference on Lung Cancer (WCLC).
In 2019, the combination therapy of Rivoceranib and EGFR-TKIs such as Erlotinib, Gefitinib, Icotinib, Afatinib, and Osimertinib (which are standard treatments for non-small cell lung cancer) showed outstanding efficacy. Especially, it was reported that it showed 95.5% of DCR in combination with conventional drugs and Rivoceranib within patients with resistance to EGFR-TKI. In addition, with Rivoceranib (monotherapy), patients who failed to treat cytotoxic anticancer drugs for small cell lung cancer showed 6.18 months of Progress-Free Survival (PFS), 19.35% of ORR and 83.87% of DCR, and in clinical trial phase 2 of combination therapy with cytotoxic anticancer drugs, it showed 33.3% of ORR and 93.3% of DCR.
4. Meaning: Rivoceranib's value expansion and HLB's Royalty increase
(1) According to data released by the World Health Organization (WHO) in 2018, lung cancer is the number 1 cancer incidence rate and mortality rate in total, with 2,093,876 patients and 1,761,007 deaths worldwide.
(2) Currently, lung cancer treatment is subdivided according to markers such as EGFR, ALK, ROS1, and PD-L1.
(3) Rivoceranib has been clinically tested with several combination treatments for various lung cancer patients in China. Among them, Hengrui Medicine decided to conduct a commercial phase 3 clinical trial as a primary treatment for non-small cell lung cancer in combination with EGFR targeted Gefitinib and PD-1 targeted Camrelizumab, respectively.
(4) Although there are various markers for lung cancer, the strength of Rivoceranib in both clinical trials has been confirmed once again as a drug optimized for combination therapy due to its high efficacy and low side effects.
(5) HLB, which acquired global rights (including China) from Advenchen Laboratories (a developer of Rivoceranib) on February 27, believes that the increase in sales resulting from the expansion of Hengrui Medicine's indications is directly related to the increase of HLB's royalties for income.