On November 29, 2023 AbbVie (NYSE: ABBV) reported topline results from the single-arm Phase 2 LUMINOSITY trial evaluating telisotuzumab-vedotin (Teliso-V) in patients with c-Met protein overexpression, epidermal growth factor receptor (EGFR) wild type, advanced/metastatic nonsquamous non-small cell lung cancer (NSCLC) (Press release, AbbVie, NOV 29, 2023, View Source [SID1234638055]). The results demonstrated a compelling overall response rate per independent central review (ICR) of 35 percent and 23 percent across c-Met High and c-Met Intermediate patients respectively.

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In addition, other endpoints demonstrated meaningful clinical outcomes including median duration of response per ICR of 9 months and 7.2 months and a median overall survival of 14.6 months and 14.2 months across c-Met High and c-Met Intermediate patients respectively.

The safety profile of Teliso-V was consistent with previous findings and no new safety concerns were identified. Adverse events with Teliso-V monotherapy were generally well managed and tolerated. Full data from the LUMINOSITY study will be presented at a future medical meeting and we will discuss with global health authorities the potential to support an accelerated approval.

Approximately 85% of lung cancers are classified as NSCLC1 and despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths in both men and women throughout the world.2 C-Met protein overexpression is found in approximately 25% of advanced EGFR wild type NSCLC patients3 and is associated with a poor prognosis for these patients.4,5,6 Teliso-V, an investigational ADC, is being studied in this patient population who have very limited treatment options and where there are currently no approved therapies.

"The results of the Phase 2 LUMINOSITY trial are encouraging for those patients with non-small cell lung cancer with c-Met overexpression as there is a critical need for better care and additional therapy options for them," said Ross Camidge, MD, PhD, University of Colorado Cancer Center, United States, and Principal Investigator for the trial. "Today’s announcement also provides confidence as we continue to enroll patients into the Phase 3 TeliMET NSCLC-01 trial and expand our understanding of Teliso-V’s potential."

"Results from the Phase 2 LUMINOSITY trial mark an important step forward for AbbVie’s mission to advance new oncology treatments across our ADC program targeting solid tumor types with critical patient needs," said Roopal Thakkar, M.D., senior vice president, development and regulatory affairs and chief medical officer, AbbVie.

Teliso-V is being evaluated as a monotherapy in patients with previously treated c-Met overexpressing EGFR wild type nonsquamous NSCLC in the randomized Phase 3 study TeliMET NSCLC-01, which is currently enrolling.

Teliso-V has also been granted several designations around the world including Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) and Taiwanese health authorities, SAKIGAKE designation in Japan by the Ministry of Health, Labour and Welfare (MHLW), as well as being awarded an Innovation Passport by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

About Telisotuzumab-Vedotin (Teliso-V)
Teliso-V is an investigational first-in-class, c-Met protein directed antibody-drug conjugate (ADC) targeting patients with c-Met overexpressing tumors. C-Met is a receptor tyrosine kinase that is overexpressed in many solid tumors including NSCLC. Teliso-V is being evaluated as a monotherapy in patients with previously treated c-Met overexpressing EGFR wild type non squamous NSCLC in the randomized Phase 3 study TeliMET NSCLC-01, which is currently enrolling. In addition, it is being evaluated in combination with osimertinib in the ongoing Phase 1 study M14-237, and as a monotherapy in the Phase 2 LUMINOSITY study. Further information on clinical trials for Teliso-V is available at View Source Currently there are no approved cancer therapies specifically for patients with c-Met overexpressing NSCLC. Teliso-V is not approved by any regulatory authority and its safety and efficacy have not been established.

About the LUMINOSITY trial
The LUMINOSITY trial (M14-239), is an ongoing Phase 2 study designed to identify the target NSCLC populations that overexpress c-Met best suited for Teliso-V monotherapy in the second line or third line setting, and then to expand the groups to further evaluate efficacy in the selected populations. The endpoints include overall response rate (ORR), duration of response (DoR), disease control rate (DCR) and progression-free survival (PFS) per independent central review (ICR) as well as overall survival (OS).