Cellular Biomedicine group developed the therapy after efficacy was seen with Iovance’s lifilecuel in solid tumor studies.
The FDA has granted clearance of Cellular Biomedicine Group’s investigational new drug application (IND) of CT-TIL051, a tumor infiltrating lymphocyte (TIL) therapy for the potential treatment of non-small cell lung cancer (NSCLC).1
Cellular Biomedicine will proceed shortly with a first-in-human phase 1 trial for patients with NSCLC whose disease has relapsed or is refractory to anti-PD1 therapy.
"This is outstanding news for NSCLC patients who are faced with limited treatment options. C-TIL051 could potentially offer an alternative treatment and our preclinical data show that C-TIL051 might have the potential to be superior. We are working closely with clinical sites and plan to initiate the C-TIL051 Phase 1 trial soon," Tony (Bizuo) Liu, chairman, chief executive, and chief financial officer, Cellular Biomedicine, said in a statement.1 "FDA clearance of the C-TIL051 IND is a significant milestone for CBMG. We plan to start manufacture of clinical batches of C-TIL051 in our GMP facility at Rockville Maryland in the near future."
C-TIL015 is an autologous, adoptive TIL cell therapy developed using the company’s proprietary manufacturing process at its good manufacturing process facility in Rockville, Maryland. The process allows the TIL cells to produce more clinical doses faster and more efficiently than traditional TIL manufacturing methods in a 2-step process.
The therapy has not been evaluated in humans before but the rationale for developing it was based on Iovance Biotherapeutic’s lifileucel TIL phase 1 (NCT03215810) and 2 (NCT03645928) studies in solid tumors, including NSCLC. The phase 2 study demonstrated an 85.7% overall response rate (ORR) of lifileucel in combination with pembrolizumab in patients with advanced melanoma with a manageable safety profile.
Another phase 2 study (NCT02360579) evaluated lifileucel in 178 participants in metastatic melanoma.3 In this study, ORR was 35% (95% CI, 23.5-47.6) in 66 participants in cohort 2 with 5 CRs and 18 PRs. ORR was 29% (95% CI, 19.5-39.4) in participants in cohort 4 who had a higher baseline disease burden than cohort 2. Overall, ORR for participants in cohorts 2 and 4 was 31% (95% CI, 24.1-39.4) and median DOR was not reached with a median follow-up of 27.6 months.
Iovance has since initiated a rolling biologics license application (BLA) for lifileucel to treat unresectable or metastatic melanoma that progressed on or after prior anti-PD-1/L1 therapy, and if BRAF mutation positive, also prior BRAF or BRAF/MEK inhibitor therapy.4 The initiation was announced in August 2022 and expects to be completed by the fourth quarter of 2022.
“Lifileucel represents hope and a new treatment for thousands of people with advanced melanoma who have very limited options after they progress on available standard of care,” Kyleigh LiPira, chief executive officer, Melanoma Research Foundation, said in a statement.4 “Cell immunotherapies are revolutionizing cancer treatment, and we are excited about the potential for the first FDA-approved TIL cell therapy for the treatment of melanoma, which helps us take another step towards finding a cure.”