The latest research results from the subcutaneous injection of PD-L1 antibody envafolimab (KN035) at the ASCO, 2020 Annual Meeting

3D Medicines is a clinical-stage biopharmaceutical company focused on the development of differentiated next-generation immuno-oncology drugs for cancer patients. 3D Medicines recently reported on the presentation of poster #3021 at ASCO 2020, entitled “Envafolimab (KN035) in Advanced Tumors with Mismatch-Repair Deficiency,” which showed that single agent envafolimab demonstrated a 30% confirmed ORR in 50 patients with MSI-H/dMMR colorectal cancer who failed a fluoropyrimidine, oxaliplatin and irinotecan (n=39) plus those with advanced gastric cancer (GC) who failed at least one prior systemic treatment (n=11), with at least two on-study tumor assessments. It is highly consistent with the data of FDA approved PD1 inhibitors Keytruda and nivolumab in the same indications.

Envafolimab (KN035) is the world's first PD-L1 antibody formulated for subcutaneous injection. It is stable at room temperature, saves patients' medication time, improves patients' compliance, and significantly improves patients' quality of life. Compared with the currently marketed and under development PD(L)-1 antibodies, Envafolimab (KN035) has the clear advantages in reduced utilization of medical resources and improved convenience and compliance of treatment, which are important considerations as cancer is increasingly becoming a chronic disease.

Advanced solid tumors mismatched to repair defects
Research topic: Envafolimab (KN035) in Advanced Tumors with Mismatch-Repair Deficiency
Abstract No. : 3021; Clinical Trial registration Number: NCT03667170
Release Date: May 29, 2020, 8:00AM-11:00AM (US time)
May 29, 2020, 8:00Pm-11:00pm (Beijing time)

Background: This open-label pivotal  Phase II study assessed the safety and antitumor activity of KN035 in patients with advanced MSI-H/dMMR cancer.
Methods: The single arm, open label, multicenter study was a pivotal clinical trial exploring Envafolimab in the treatment of MSI-H/dMMR advanced solid tumors.  The primary endpoint was a confirmed objective response rate (ORR) as assessed by an independent review committee. MSI-H/dMMR status for colorectal cancer (CRC) and gastric cancer (GC) was confirmed in a central laboratory, while other tumors were assessed in local laboratories.


Research results:

As of December 17, 2019, 103 patients with advanced MSI-H/dMMR cancer had been recruited from 25 centers in China.
The primary outcome group (PEPi) included 39 patients with advanced CRC who had received at least fluorouracil, oxaliplatin, and irinotecan treatment, and 11 patients with advanced GC who had received at least first-line standard treatment. The median follow-up time was 7.5 months.
The overall population included 65 CRC (24 patients previously treated with fluorouracil and oxaliplatin or irinotecan ), 18 patients with gastric cancer and 20 other tumor types, with a median follow-up of 6.7 months.
Key highlights include:

√  The confirmed objective response rate (ORR) in the PEPi population was 30% (95%CI: 17.9%, 44.6%), and 80% of the responses were ongoing at the time of  data cutoff.

√  In CRC patients previously treated with fluorouracil and oxaliplatin or Irinotican, the ORR was 54.2% (95%CI: 32.8%, 74.4%) and 84.6% of responses were ongoing at the time of  data cutoff.

√  The confirmed objective response rate in the general population was 34.0% (95%CI: 24.9%, 44.0%), and 85.7% of responses were ongoing at the time of data cutoff.

Main efficacy results:

√  The median progression-free survival in both the PEPi and the general population was 6.6 months. Median for overall  survival in both populations was not reached. Grade 3-4 treatment-related adverse events (TRAE) occurred in 14 patients (13.6%). There have been no reports of grade 5 TRAE, pneumonitis,  or colitis. Local injection site reaction occurred in 9 patients, all of which were grade 1 or 2.

Drug-related adverse events

Envafolimab demonstrated robust durable antitumor activity in patients with previously treated advanced MSI-H/dMMR cancer

About KN035
Invented by Alphamab, being co-developed with 3D Medicines, KN035 is a fusion protein of PD-L1 single domain antibody with the Fc domain of a regular antibody. Based on its unique design, KN035 has advantages in safety, convenience, and compliance over conventional PD-(L)1 antibodies. It can be used for patients who are not suitable for intravenous infusion, and has lower overall medical costs.
Currently, KN035 is undergoing clinical trials in China, the United States, and Japan for multiple cancer indications, and it has entered pivotal trials for some cancer indications. Envafolimab (KN035) received  orphan drug designation for advanced biliary cancer by FDA of the United States. Initial NDA submission for envafolimab in China is expected in 2020.
About 3D Medicines
3D Medicines is a clinical stage biopharmaceutical company that adheres to the ‘patient-centered’ principle. In anticipation of a future when cancer is being treated as a chronic disease, the company focuses on the development of differentiated next-generation immune-oncology therapies to help cancer patients worldwide live longer and better. The company’s pipeline includes differentiated biologics and small molecule anti-cancer treatments. 3D Medicines has a seasoned team with global talents that is capable of conducting global clinical development and registration of oncology products.
Visit: for more information.