ASCO 2021 | Ascentage Pharma announces updated results, demonstrating the clinical potential of Alrizomadlin (APG-115) plus Pembrolizumab in patients with advanced solid tumors who have failed oral immunotherapy

SUZHOU, China with Rockville, Maryland, May 19, 2021 /PRNewswire/-Ascentage Pharma (6855.HK), the world’s leading clinical stage biotechnology company, is committed to developing new therapies for cancer, chronic hepatitis B (CHB) and age-related diseases, today announced the summary report covering the following two The clinical study evaluating the company’s drug candidate Alrizomadlin (APG-115) has been published on the official website of the 2021 American Society of Clinical Oncology (ASCO) annual meeting. Among them, in patients with unresectable or metastatic melanoma or advanced solid tumors who have failed immuno-oncology drug treatment, the phase II study of arizomoline combined with pembrolizumab has shown good results, including a disease control rate of 60.9% (DCR ) And objective response In the PD-1/PD-L1 inhibitor-resistant melanoma cohort, the incidence of ORA was 17.4%.

The latest results of this research will be published in the form of an oral report at the ASCO annual meeting, which will June 4-8, 2021. This year, the summary reports of four clinical studies on Ascentage Pharma’s three apoptosis target drug candidates have been selected for the ASCO annual meeting, and two have been selected for oral presentations.

“Alrizomadlin is our core drug candidate for targeting apoptosis and has great potential in the treatment of advanced solid tumors. These data of the combination of alrizomadlin and pembrolizumab are promising because they indicate a potential new treatment option for patients with solid tumors. ,” said the doctor Yifan Zhai, Chief Medical Officer of Ascentage Pharma. “In addition, these results, which will be published at the ASCO annual meeting in 2021, demonstrate our progress in promoting the research and development of therapies against apoptosis. We will work to further accelerate the global clinical development plan for these novel therapies so that Patients benefit from China And as soon as possible on a global scale. “

The two abstracts about APG-115 that will be released at this year’s ASCO annual meeting are as follows (the other two abstracts are simultaneously published in a separate press release):

A novel small molecule MDM2 inhibitor alrizomadlin (APG-115) in combination with pembrolizumab for patients with advanced solid tumors (pts) who have failed unresectable or metastatic melanoma or immuno-oncology treatments (preliminary results of a phase II study)

Format: oral presentation
Summary: #2506
time: 15:00-18:00 EST, June 7, 2021
Session: Developmental Therapy—Immunotherapy
Emphasize:

• This open-label, multicenter phase II study conducted in the United States evaluated the safety, tolerability, PK, PD, and anti-tumor activity of arizotaline combined with pembrolizumab in patients with advanced solid tumors.
• As December 25, 2020, 84 patients have participated in the Phase II study of the study, and received a 150mg RP2D dose of arizomod combined with pembrolizumab every other day. The study has 6 cohorts, including: PD-1/PD-L1 inhibitor-resistant melanoma, non-small cell lung cancer (NSCLC) and urothelial carcinoma; or malignant peripheral nerve sheath tumors that have failed to any standard treatment ( MPNST), liposarcoma and ATM mutant solid tumors.
• Anti-tumor effect:
• In the PD-1/PD-L1 inhibitor-resistant melanoma cohort (n = 26), out of 5 uveal (ocular) melanoma patients, 1 case was diagnosed with PR. 5 patients with mucosal melanoma had 2 PRs (1 confirmed + 1 undiagnosed); 1 out of 11 cutaneous melanoma patients had PR (confirmed). The ORR and disease control rate (DCR) of the melanoma cohort were 17.4% (4/23) and 60.9% (14/23), respectively.
• In the MPNST queue (n =3), 1 ongoing PR (not confirmed).
• In the PD-1/PD-L1 inhibitor-resistant NSCLC (n = 14, evaluable) and urothelial carcinoma (n = 5, evaluable) cohorts, 1 patient in each cohort was diagnosed with PR.
• Common treatment-related adverse events (TRAE) observed in more than 10% of patients are nausea, thrombocytopenia, vomiting, fatigue, decreased appetite, diarrhea, neutropenia, and anemia.
• In summary, the combined use of arizotaline and pembrolizumab is well tolerated, and can restore anti-tumor effects in cancer patients who are resistant or intolerant to IO drugs.

Ongoing trial: Phase I/II clinical trial of a new MDM2 inhibitor alrizomadlin (APG-115) with or without platinum-based chemotherapy for patients with p53 wild-type salivary gland cancer

Format: Poster presentation
Summary: #TPS6094
time: 09:00 EST, June 4, 2021
Sub-venue: Head and Neck Cancer
Emphasize:

• This open-label, multi-center phase I/II clinical trial conducted in the United States aims to evaluate the safety, DLT, MTD and anti-tumor activity of arizotaline in wild-type patients with or without platinum-based chemotherapy TP53 Salivary gland cancer.
• This research is divided into two parts:
• Part 1: Two-arm randomized study (allocated in a ratio of 1:2, n = 42)
• Group A: Alizotalin as a single agent (n = 14)
• Group B: Alizotalin plus platinum chemotherapy (n = 28)
• Part 2: Single-arm research (starting with the most promising part of the first part (n = 20))
• Research endpoint:
• DLT based on grade 3 to 5 TRAE (through NCI CTCAE v5.0) in the first 6 weeks (2 cycles) of treatment.
• DLT-based MTD during the same treatment period.
• ORR is based on the proportion of patients who have been diagnosed with CR or PR (according to RECIST v1.1) for up to 12 months.
• This study aims to recruit 42 patients.As January 27, 2021, 11 patients have been enrolled in the group.
  

About Ali Zuozolin (APG-115)

Alrizomadlin, developed by Ascentage Pharma, is a selective small molecule inhibitor of MDM2 protein for oral administration. Alrizomadlin has a strong binding affinity to MDM2, and aims to activate the tumor suppressor activity of p53 by blocking the interaction between MDM2-p53 protein and protein. Alrizomadlin is the first MDM2-p53 inhibitor to enter clinical development China Research is currently underway in multiple phase Ib/II studies for solid tumors and hematological malignancies. China, Australia, And the United States.

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a global, clinical-stage biotechnology company dedicated to the development of new therapies for cancer, chronic hepatitis B and age-related diseases.on October 28, 2019, Ascentage Pharma is listed on the main board of The Stock Exchange of Hong Kong Limited, stock code: 6855.HK.

Ascentage Pharma focuses on developing therapies that can inhibit protein-protein interactions to restore apoptosis or programmed cell death. The company has established a product line including eight clinical drug candidates, including new and highly effective Bcl-2 and Bcl-2/Bcl-xL dual inhibitors, as well as drug candidates for the IAP and MDM2-p53 pathways, and the next generation Tyrosine. Kinase inhibitor (TKI). Ascentage Pharma is also the only company in the world that has an effective clinical plan for all three known key regulators of apoptosis. The company is conducting more than 40 phase I/II clinical trials in the United States, Australia, Europe with China. The company’s core drug candidate Olverembatinib (HQP1351) has been developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and has been awarded the Orphan Drug Designation (ODD) and Fast Track Designation (FTD) by the US FDA. The New Drug Application (NDA) of olverembatinib has been submitted, and was subsequently granted priority review status and breakthrough therapy designation (BTD) by the Center for Drug Evaluation (CDE). China. So far, Ascentage Pharma has obtained 11 ODDs of the company’s 11 drug candidates from the US FDA.

Forward-looking statements

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SOURCE Shenghua Pharmaceutical