AXL Inhibitors Market Assessment and Forecast – Competition Landscape, Commercial, and Pipeline Analysis, 2023-2029

AXL inhibitors are an orally bioavailable and selective inhibitor of the receptor tyrosine kinase AXL (UFO), with potential immunostimulant and antineoplastic activities. This blocks AXL-mediated signal transduction pathways and inhibits both AXL-mediated tumor cell growth, proliferation, migration, and AXL-mediated immunosuppression. AXL is a member of the Tyro 3, AXL, and MERTK (TAM) receptor tyrosine kinase family and is overexpressed by many tumor cell types and expressed in a variety of immune cells including macrophages, natural killer (NK) cells, and regulatory T cells. It plays a key role in tumor cell proliferation, survival, invasion, metastasis, and is a mediator of immunosuppression. AXL inhibitor has a predominant role in treating leukemia, AIDS-HIV, respiratory diseases, bone cancer, CNS neoplasm, and digestive system diseases.

According to World Cancer Research Fund 2020, There were an estimated 18.1 million cancer cases around the world and 4,74,519 new cases of Leukaemia in 2020 and it expected to be 28.4 million cases in 2040, a 47% rise from 2020. Moreover, the launch of newer products by the market players significantly enhances the revenue of AXL inhibitors market over the forecast years. For instance, Exelixis are currently providing AXL inhibitors Cabometyx for the treatment of renal cell carcinoma, Cometriq for the treatment of metastatic medullary thyroid cancer, and Astellas providing Xospata for the treatment of acute myeloid leukemia. Simultaneously, many players developing molecules for treatment of many other tumors. For instance, Mirati’s MGCD516 for cancer, BerGenBio’s BGB324 for resistant cancer, Eli Lilly’s LY2801653 for advanced biliary tract cancer, Pfizer’s PF-07265807 for solid tumor, and Roche’s RXDX-106 for metastatic solid tumors are under the various stages of clinical studies.

Key Market Developments:

• In September 2021, FDA approved Cabometyx (Cabozantinib), for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer.
• In April 2021, GlaxoSmithKline agreed to sell its royalty stake to Royalty Pharma in two Cabozantinib drugs under the trade names Cabometyx and Cometriq.

Approved Drug Molecules with Brand Names for AXL Inhibitors:

• Cabometyx (Cabozantinib tablet)  - Exelixis
• Cometriq (Cabozantinib capsule) - Exelixis
• Xospata (Gilteritinib) - Astellas

Drugs under the Pipeline for AXL Inhibitors:

• Sitravatinib (MGCD516) - Mirati
• Bemcentinib (BGB324) - BerGenBio
• Merestinib (LY2801653) - Eli Lilly
• Glesatinib (MGCD265) - Mirati
• AL2846 - Advenchen, Sino Biopharm
• SLC-391 - SignalChem Lifesci
• Zanzalintinib (XL092) - Exelixis
• PF-07265807 - Pfizer
• RXDX-106 - Roche

Clinical Activity and Developments of AXL Inhibitors:

As of June 2023, more than 30 companies have approximately 30 molecules for above 130 diseases. For these molecules, more than 240 clinical trials are being conducted by the players across the globe. For instance,

• In 2019, in Phase 3, ADMIRAL Trial Data Show XOSPATA (Gilteritinib) Significantly increases Overall Survival in Adult Patients with FLT3 Mutation-Positive Relapsed Acute Myeloid Leukemia
• In August 2022, Cabozantinib and checkpoint inhibitors Atezolizumab demonstrated significant clinical activity in COSMIC-312 trial for advanced hepatocellular carcinoma.