Candel Therapeutics, Inc. CADL on Wednesday revealed remaining survival information from a part 2a trial of CAN-2409 in sufferers with stage III/IV NSCLC, inadequately responding to Immune Checkpoint Inhibitor (ICI) remedy.
The median total survival (mOS) was 24.5 months in 46 evaluable sufferers receiving 2 programs of CAN-2409 and 21.5 months in evaluable sufferers from cohort 2 (n=41) that introduced with progressive illness at baseline, despite ICI treatment.
The corporate on Wednesday stated mOS in sufferers with progressive illness regardless of ICI remedy was 9.8-11.8 months in different research, together with these with commonplace of care of docetaxel chemotherapy.
This remaining evaluation included prolonged follow-up information (1 yr after the earlier information reduce), with a median follow-up time for the per-protocol inhabitants of 32.4 months.
Information confirmed a large proportion of sufferers with survival exceeding 24 months, proof of an extended tail of survival, with 37% of sufferers with progressive illness regardless of remedy with ICI alive 2 years after CAN-2409 administration.
Biomarker analysis confirmed an enhanced immunological and medical response after CAN-2409 administration in sufferers with non-squamous histology in comparison with squamous histology, and improved mOS was noticed on this inhabitants (25.4 months in sufferers with progressive illness regardless of ICI remedy and non-squamous NSCLC, n=33).
Systemic anti-tumor response (abscopal impact) and security profile:
- A lower within the dimension of uninjected tumors was noticed in 69% of sufferers with a number of lesions (n=35), indicating that native injection could induce a systemic anti-tumor immune response (abscopal impact).
- CAN-2409 maintained its typically favorable security and tolerability profile all through the prolonged follow-up interval.
The U.S. Meals and Drug Administration (FDA) beforehand granted Quick Monitor Designation for CAN-2409 plus valacyclovir together with ICI remedy for the remedy of stage III/IV NSCLC in sufferers who’re proof against first-line PD-(L)1 inhibitor remedy and who should not have activating molecular driver mutations or have progressed on directed molecular remedy.
Value Motion: CADL is down 7.93% at $6.91 on the final examine Thursday.
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