TRACON Pharmaceuticals Announces Presentation of Positive Clinical Data for Envafolimab in MSI-H/dMMR Cancer at ASCO 2020 Virtual Scientific Program by its Corporate Partners 3D Medicines and Alphamab
Envafolimab Demonstrated a 30% Confirmed Objective Response Rate (ORR) by RECIST by Independent Central Review in Patients with Advanced Refractory MSI-H/dMMR Colorectal and Gastric Cancer
ORR and Other Data will be Updated at ASCO
TRACON Expects to Initiate its Pivotal ENVASARC Trial of Envafolimab in Sarcoma in Second Half of 2020
ASCO abstract #3021 entitled “Envafolimab (KN035) in Advanced Tumors with Mismatch-Repair Deficiency” reviewed data available on
Key highlights included:
- The confirmed ORR in 50 patients with CRC who failed a fluoropyrimidine, oxaliplatin and irinotecan (n=39) plus those with advanced GC who failed at least one prior systemic treatment (n=11), with at least two on-study tumor assessments, was 30% (95% CI: 18%, 45%), of whom 80% were responding with median follow-up of 7.5 months at the time of the data cutoff.
- The confirmed ORR in the overall population (n=103) was 34% (95% CI: 25%, 44%), of whom 86% were responding with median follow-up of 6.7 months at the time of the data cutoff.
- The confirmed ORR in 24 patients with CRC who failed a fluoropyrimidine and oxaliplatin or irinotecan (n=24) was 54% (95% CI: 33%, 74%) of whom 85% were responding at the time of the data cutoff.
- Envafolimab was well tolerated with a safety profile similar to that of approved PD-(L)1 checkpoint inhibitors but without infusion related reactions.
“We are impressed by the confirmed ORR of envafolimab from its pivotal trial in Chinese patients with MSI-H/dMMR cancer, which is a genetically defined tumor type,” said
The complete abstract is available at: https://meetinglibrary.asco.org/record/189156/abstract
About Envafolimab
Envafolimab is a novel, single-domain antibody against PD-L1 that is administered by subcutaneous injection without the need for an adjuvant. Envafolimab is currently dosing in Phase 1 trials in the
About TRACON
TRACON develops targeted therapies for cancer utilizing a capital efficient product development platform. The Company’s clinical-stage pipeline includes: Envafolimab, a subcutaneous PD-L1 single-domain antibody being developed for the treatment of sarcoma with the goal of starting a registrational trial in the
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Source: TRACON Pharmaceuticals, Inc.