TRACON Pharmaceuticals Reports Regulatory Approval of Envafolimab in China
First Approval of a Subcutaneously Administered Checkpoint Inhibitor
Envafolimab was approved for adult patients with microsatellite instability-high (MSI-H) or deficient MisMatch Repair (dMMR) advanced solid tumors, including those patients with advanced colorectal cancer who have experienced disease progression following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as well as patients with other advanced solid tumors who have experienced disease progression following prior systemic treatment and have no satisfactory alternative treatment options.
Prior to this approval, all marketed PD-1 and PD-L1 antibody drugs required intravenous infusions. As a subcutaneously administered PD-L1 antibody, envafolimab can be administered within 30 seconds in the physician’s office—thereby increasing convenience, shortening treatment time and sparing patients from the risk of infusion reactions.
In a pivotal phase 2 clinical study in patients with advanced dMMR/MSI-H tumors who received one or more lines of treatment, envafolimab demonstrated an objective response rate (ORR) by blinded independent radiographic review (BIRR) of 44.7%, including 12 (11.7%) cases of complete response. Responses were durable, with duration of response at 12 months in responding patients with advanced colorectal cancer (CRC), advanced gastric cancer, other advanced solid tumors, and all responding patients of 89%, 100%, 100%, and 93%, respectively. Median progression-free survival was 11.1 months and the 12-month overall survival rate was 73.6%. The confirmed ORR by BIRR in MSI-H/dMMR CRC patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 32%, which was similar to the 28% confirmed ORR reported in the OPDIVO® package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan treatment and the 33% confirmed ORR reported for KEYTRUDA® in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan treatment in cohort A of the phase 2 KEYNOTE-164 trial. Envafolimab was well tolerated in this study and no cases of immune-related pneumonitis, immune-related colitis, or immune-related nephritis were reported.
“We are pleased the dedication of our partners
Envafolimab (KN035), a single-domain antibody against PD-L1 invented by
About ENVASARC (NCT04480502)
The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in
TRACON develops targeted therapies for cancer utilizing a capital efficient, CRO independent, product development platform. The Company’s clinical-stage pipeline includes: Envafolimab, a PD-L1 single-domain antibody given by rapid subcutaneous injection that is being studied in the pivotal ENVASARC trial for sarcoma; YH001, a potential best-in-class CTLA-4 antibody in Phase 1 development; TRC102, a Phase 2 small molecule drug candidate for the treatment of lung cancer; and TJ004309, a CD73 antibody in Phase 1 development for the treatment of advanced solid tumors. TRACON is actively seeking additional corporate partnerships whereby it leads
About 3D Medicines
3D Medicines is a clinical-stage biopharmaceutical company focused on the development of differentiated next-generation immuno-oncology drugs for cancer patients. The world's first subcutaneous injection PD-L1 antibody, envafolimab, is currently under clinical development in
Statements made in this press release regarding matters that are not historical facts are “forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding TRACON's and its collaboration partners’ plans to further develop product candidates; expectations regarding the timing and scope of clinical trials and availability of clinical data; expected development, regulatory and commercial milestones and timing thereof; potential utility of product candidates; and TRACON’s business development strategy and goals to enter into additional collaborations. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: risks associated with clinical development and regulatory approval of novel pharmaceutical products; whether TRACON or others will be able to complete or initiate clinical trials on TRACON’s expected timelines, if at all, including due to risks associated with the COVID-19 pandemic; the fact that future preclinical studies and clinical trials may not be successful or otherwise consistent with results from prior studies; the fact that TRACON’s collaboration agreements are subject to early termination; whether TRACON will be able to enter into additional collaboration agreements on favorable terms or at all; potential changes in regulatory requirements in
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Source: TRACON Pharmaceuticals, Inc.