The author is an analyst for NH Investment & Securities. He can be reached at pk.park@nhqv.com -- Ed.
Recent ELCC data released by J&J proves that the expanded adverse reactions seen during phase III trials of Mariposa can be managed. With approval expected mid-year, now is the time to pay attention to drug prices.
ELCC Mariposa update—adverse reactions can be managed
After Yuhan’s Mariposa phase III disclosure at ESMO last year, the firm’s share price plunged due to misleading PFS comparisons with other clinical trials such as FLAURA2 (not in the same controlled environment) and expanded adverse reactions. Since then, however, while no new data was released, the firm’s share price continued to rebound, as overall market sentiment turned favorable.
On Mar 21, at the European Lung Cancer Congress (ELCC) 2024, J&J released data regarding patients that discontinued use of amivantamab within the first four months due to adverse reactions of Grade 2 or higher. The main takeaways are as follows: 1) the overall patient group experienced a significant reduction in adverse reactions after the first four months; 2) patients with high adverse reactions can manage their symptoms by discontinuing use of amivantamab; and 3) there is no difference in efficacy between the group that discontinued amivantamab use and the maintenance group. Concerns over injection-related adverse reactions, the most common adverse reactions, should also be resolved once results from the PALOMA-3 phase 3 (SC formulation change) are released this year.
Pay attention to drug prices as approval time approaches; what does Jansen think?
With accelerated FDA approval scheduled for mid-year, now is the time to pay attention to drug prices. Based on WAC, the monthly price of Tagrisso is US$17,000, and the price of amivantamab is US$20,000 for the first month and US$10,000 thereafter. We expect the price of Tagrisso, a standard treatment, and Mariposa’s superior clinical data compared to Tagrisso to be taken into consideration. From Janssen's perspective, the usability of Lazertinib monotherapy and the possibility of additional combination treatments using Lazertinib, such as TROP2 ADC (replacement for amivantamab), are reasons to give weight to Lazertinib pricing. The 2024 ELCC data could also have a positive impact on the price of Lazertinib.