Tumour infiltrating lymphocytes
In Cohort 2 of a PhII trial (NCT02360579 is recruiting) all the metastatic melanoma patients had progression on/after prior anti-PD-1 therapy and, if BRAF mutation positive, after BRAF (+/- MEK) inhibitor(s). Also, 79% had received prior anti-CTLA-4. In addition, they were using bulk TIL. The overall response rate (tumour shrinkage) was 38% (n=21/55) and disease control rate was 76% (n=42/55). At a median follow-up of 7.4 months, four responders progressed.
Then there are preliminary results from a PhII trial (NCT03108495 is recruiting), in patients with recurrent/metastatic/refractory cervical cancer (average of 2.6 prior lines of therapy). The overall response rate was 44% (n=12/27) and disease control rate was 89% (n=24/27). Eleven of the 12 responders maintained their responses at a median follow-up of 3.5 months. Improved responses were observed in 4 patients with longer follow-up. By comparison, the overall response rate for Keytruda in a second-line setting is 14%.