Ascent Pharma's MDM2 inhibitor APG-115 combined with pembrolizumab has good prospects for the treatment of solid tumor patients resistant to immuno-oncology drugs

A research and development company in the clinical stage dedicated to the development of innovative drugs in the treatment of tumors, hepatitis B and aging-related diseases - Ascent Pharmaceuticals announced that the American Society of Clinical Oncology (ASCO) has today announced the company's drug Alrizomadlin on its official website.
(APG-115) Abstracts of two clinical studies
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Among them, the Phase II clinical study of APG-115 combined with pembrolizumab in patients with unresectable/metastatic melanoma or advanced solid tumors who have failed immuno-oncology drug therapy has shown good prospects

The latest progress of the research will be further demonstrated in the form of an oral report at the ASCO annual meeting to be held from June 4 to 8, 2021
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This year, Ascent Pharmaceuticals has four clinical studies of three types of apoptosis pipeline selected for the ASCO annual meeting to display and report, including two oral reports

"APG-115 is an important product under development in the Apoptosis product pipeline of
Ascent Pharmaceuticals and has great potential in the treatment of advanced solid tumors .
The clinical trial of APG-115 combined with Pembrolizumab will be demonstrated at the 2021 ASCO annual meeting.

The abstracts of the two studies selected by APG-115 for the 2021 ASCO annual meeting are as follows (the abstracts of the other two selected studies of Yasheng Pharmaceutical are listed in another press release issued at the same time):

Preliminary results of a phase II study of alrizomadlin (APG-115), a novel, small-molecule MDM2 inhibitor, in combination with pembrolizumab in patients (pts) with unresectable or metastatic melanoma or advanced solid tumors that have failed immuno-oncologic (IO ) drugs

Preliminary results of a phase II clinical study of APG-115 combined with pembrolizumab in patients with unresectable / metastatic melanoma or advanced solid tumors who have failed immuno-oncology drug therapy

Presentation format: Oral report

• This is an open, multi-center Phase II study conducted in the United States to evaluate the safety, tolerability, PK, PD and anti-tumor activity of APG-115 combined with pembrolizumab in patients with advanced solid tumors
  
  

  Trial in progress: A phase I/II trial of novel MDM2 inhibitor alrizomadlin (APG-115), with or without platinum chemotherapy, in patients with p53 wild-type salivary gland carcinoma

  Phase I/II clinical study of APG-115 single agent or combined with platinum chemotherapy in the treatment of p53 wild-type salivary gland carcinoma

  Display format: poster display
  Abstract number: #TPS6094
  Time: Beijing time 2021.
  6.
  4, 21:00 / US Eastern time 2021.

  
  6.
  4, 09:00
  
  
  • This is an open-label, multi-center, phase I/II study conducted in the United States to evaluate the safety, DLT, MTD, and resistance of APG-115 single-agent or combined platinum-based chemotherapy in patients with p53 wild-type salivary cancer.
    Tumor activity
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  • This research is divided into two parts:
    • Part 1: Double-arm Randomized Controlled Study (Patients are allocated according to 1:2, n=42)
      • Group A: APG-115 monotherapy (n=14)
      • Group B: APG-115 + carboplatin (n=28)
    • The second part: single arm study (using the more promising treatment plan A or B in the first part, n=20)
  • Research endpoint:
    • DLT: Based on drug-related grades 3 to 5 TRAEs (according to NCI CTCAE v5.
      0) within 6 weeks (2 cycles) before treatment
    • MTD: Based on DLT during the same treatment period
    • ORR: Proportion of patients who have confirmed complete or partial remission for up to 12 months (according to RECIST v1.
      1)
  • The study plans to recruit 42 patients
    .
    As of January 27, 2021, 11 patients have been enrolled
    .