Telisotuzumab vedotin

The MET targeting therapies market is poised for significant growth by 2034 due to rising cancer diagnoses, increased awareness, and numerous therapies in clinical trials. Key players include AstraZeneca, AbbVie, and Regeneron, with therapies like ORPATHYS and Telisotuzumab Vedotin in development. Regulatory approvals and precision medicine advancements are driving market dynamics, though challenges like pricing and reimbursement persist.

Personalized therapy for NSCLC has advanced with biomarker testing, notably NGS, identifying driver mutations for targeted treatments improving OS. MET alterations in NSCLC, including exon 14 skipping mutations, are targeted by MET tyrosine kinase inhibitors like crizotinib, capmatinib, and tepotinib. RET fusions in NSCLC are addressed by selective RET inhibitors selpercatinib and pralsetinib. KRAS G12C mutations are managed with selective KRAS G12C inhibitors sotorasib and adagrasib, showing significant efficacy in clinical trials.

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AbbVie submitted a BLA to the FDA for telisotuzumab vedotin (Teliso-V) in metastatic EGFR wild-type nonsquamous NSCLC with c-Met overexpression. Data from the phase 2 LUMINOSITY trial showed ORR of 34.6%, 22.9%, and 28.6% in high, intermediate, and overall c-Met overexpression groups, respectively. Median DOR was 9.0, 7.2, and 8.3 months, and median PFS was 5.5, 6.0, and 5.7 months. No new safety signals were observed.

Global cancer cases surge, with a 79% rise in new cases among patients under 50. The highest death tolls are linked to breast, windpipe, lung, bowel, and stomach cancers. Cancer rates are projected to increase by 77% by 2050. In response, biotech firms like Oncolytics, AbbVie, BeiGene, HUTCHMED, and Enliven Therapeutics are accelerating treatment innovations, with the FDA approving 16 new oncology treatments in 2024. Oncolytics plans to submit a clinical trial for breast cancer treatment to the FDA in early 2025.

Cancer rates are surging globally, especially among patients under 50, with a 79% rise in new cases. The United Nations predicts a 77% increase by 2050. In response, the FDA has approved 16 new oncology treatments between July and September 2024. Oncolytics Biotech Inc. is making significant progress with its immunotherapeutic agent, pelareorep, in breast and pancreatic cancer treatments, aiming for FDA accelerated approval. The global oncology drug market is expected to grow at a CAGR of 11.5% to reach $564.50 billion by 2033, while the AI in oncology market is growing at a 35% CAGR.

AbbVie filed a BLA with the FDA for Teliso-V in NSCLC patients with EGFR wild type, nonsquamous, c-Met overexpression. The application is based on the Phase II LUMINOSITY trial results, showing 35% ORR in c-Met High and 23% in c-Met Intermediate patients, with median DoR of 9 and 7.2 months, and median OS of 14.6 and 14.2 months, respectively.

AbbVie submitted a BLA to the FDA for accelerated approval of telisotuzumab vedotin (Teliso-V) in EGFR wild type, nonsquamous NSCLC with c-Met overexpression, supported by Phase 2 LUMINOSITY trial data. Teliso-V received FDA Breakthrough Therapy Designation in December 2021.

AbbVie submits Biologics License Application to FDA for Teliso-V, an ADC targeting c-Met overexpression in previously treated nonsquamous NSCLC, supported by Phase 2 LUMINOSITY trial data.

AbbVie submits Biologics License Application to USFDA for Telisotuzumab Vedotin (Teliso-V), an ADC for previously treated nonsquamous NSCLC with c-Met overexpression.