Melanoma – Alrizomadlin, Fast Track Designation for Advanced Disease


The FDA has granted a Fast Track Designation to the novel MDM2-p53 inhibitor named “Alrizomadlin” (APG-115) for the treatment of patients with unresectable or metastatic melanoma that is either relapsed or refractory to previous immunotherapies.

The indication is based on preliminary data from the ongoing phase 2 APG-115-US-002 trial (NCT03611868)

About the Trial and its Results

The trial is examining the use of Alrizomadlin in several types of cancers and the preliminary results were presented at the 2021 American Society of Clinical Oncology Annual Meeting.

32 melanoma patients participated in the study. 24.1% achieved had their tumors shrunk  during the treatment.

One patient achieved complete remission of the disease.

Moreover, 55.2% of patients achieved either stabilization (control) of their disease or a reduction in lesions volume.

The drug was administered with Pembrolizumab (Keytruda).

The study also included several tumor types, including melanoma, non–small cell lung cancer (NSCLC) and STK-11–mutated lung adenocarcinomaATM-mutant and TP53 wild-type solid tumorsMDM2-amplified and TP53 wild-type liposarcoma, urothelial carcinoma and malignant peripheral nerve sheathe tumor.

The most common reasons for treatment discontinuation included progressive disease (61.8% of patients), adverse effects (18.4%), consent withdrawal (10.5%) and physician decision (4.0%).

Common Side Effects

Nausea (66.7%), decreased platelet count (43.2%) and vomiting (39.2%).

Additionally, severe side effects included decreased platelet count (22.6%), decreased neutrophil count (12.8%) and anemia (7.8%).

Hope of offering a new treatment option to patients with melanoma

Patients with relapsed/refractory unresectable or metastatic melanoma may derive benefit from Alrizomadlin, which has received a Fast Track Designation from the FDA.

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About Melanoma

Sourced in the melanocytes, cells which produce skin pigment known as melanin.

Melanoma may also begin in other pigment tissue such as the eye, or intestines. Melanoma is the rarest but more aggressive of the three types. It tends to spread to adjacent tissues, and can metastasize in the brain, lungs, bones, liver, and stomach.

Read More

  1. Ascentage Pharma’s MDM2-p53 inhibitor alrizomadlin (APG-115) granted fast track designation by the US FDA for the treatment of relapsed/refractory unresectable or metastatic melanoma
  2. About Melanoma
Melanoma – Alrizomadlin, Fast Track Designation for Advanced Disease
Melanoma – Alrizomadlin, Fast Track Designation for Advanced Disease

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