China’s Center for Drug Evaluation (CDE) has received a marketing approval application for Innovent Biologics Inc’s (HKG: 1801) PI3Kδ inhibitor parsaclisib. The product candidate has been granted priority review status. The targeted indication is relapsed or refractory follicular lymphoma (r/r FL) in patients who have previously received at least two systemic treatments.
Licensing Deal and Development Rights
In December 2018, Innovent secured Greater China development and commercialization rights to parsaclisib and two other small-molecule cancer therapies through a USD 392 million licensing deal with US firm Incyte (NASDAQ: INCY). The drug previously obtained breakthrough therapy designation (BTD) status for use in r/r FL in China in March of last year.
Clinical Trial Results
The results of the pivotal Phase II study, presented at the 63rd American Society of Hematology (ASH) annual meeting last year, showed that as of December 2021, parsaclisib achieved an 86.9% objective response rate (ORR) in 61 r/r FL patients, with 31.1% achieving complete remission (CR). The median progression-free survival (mPFS) and median overall survival (mOS) had not yet been reached. In terms of safety, 44.3% of patients experienced grade 3 or above adverse reactions, and one patient died due to multiple organ dysfunction. However, the researcher determined that the cause of death was not related to the study treatment.
Global and Domestic Landscape
Globally, several PI3K inhibitors are under development, including Gilead Sciences’ Zydelig (idelalisib), Bayer’s Aliqopa (copanlisib), Verastem’s Copiktra (duvelisib), Novartis’ Piqray (alpelisib; BYL719), and TG Therapeutics’ umbralisib. In China, other domestic companies developing similar products include BeiGene, Chia Tai Tianqing, Innovent Bio, and Sanhome.
Future Outlook
With the marketing application filed and priority review status granted, Innovent is poised to advance parsaclisib as a potential new treatment option for patients with relapsed or refractory follicular lymphoma in China.-Fineline Info & Tech
