Lung Cancer Data from AbbVie Paves Way for Accelerated ADC Approval, Falls Below Initial Benchmark

AbbVie is actively seeking accelerated approval for its promising c-Met antibody-drug conjugate (ADC), Teliso-V. In the recent update from the Luminosity trial, Teliso-V demonstrated a promising 35% overall response rate in a specific subset of patients with advanced/metastatic nonsquamous non-small cell lung cancer (NSCLC) characterized by c-Met overexpression. This particular subgroup represents approximately 25% of individuals with advanced EGFR wild type NSCLC.

To ensure a comprehensive analysis, the Luminosity trial categorized patients based on c-Met expression levels, distinguishing between high and intermediate groups. Teliso-V exhibited a notable 35% response rate in the c-Met high group, while the rate slightly declined to 23% in the c-Met intermediate cohort. It is important to note that AbbVie’s Chief Medical Officer, Dr. Roopal Thakkar, has highlighted the even distribution of the targeted patient population between these two groups.

Despite the encouraging results, the reported response rates in this update did not match the earlier data shared by AbbVie, which played a pivotal role in Teliso-V securing a breakthrough designation. The earlier data disclosed higher response rates of 53.8% and 25.0% in c-Met high and c-Met intermediate patients, respectively. However, despite the lower response rates, AbbVie presented additional data on durability, revealing a median overall survival of 14.6 months in c-Met high patients and 14.2 months in c-Met intermediate patients.

With no new safety concerns emerging from the latest findings, AbbVie is actively preparing for discussions with regulatory authorities to pursue accelerated approval for Teliso-V. Simultaneously, an ongoing phase 3 trial aims to provide comprehensive data that could support full approval in the future. If successful, Teliso-V would mark a historic achievement as the first drug approved specifically for this distinct patient population.

AbbVie’s unique focus on patients with c-Met overexpression and EGFR wild type NSCLC differentiates it in the competitive landscape. However, the company faces comparisons with other therapies, notably Johnson & Johnson’s Rybrevant—a bispecific antibody targeting both EGFR and MET. Rybrevant has already received accelerated approval for a specific subtype of NSCLC characterized by EGFR exon 20 insertion mutations.

During a quarterly results call in late October, Dr. Thakkar delved into the competitive dynamics, reflecting on data presented by other companies at the European Society of Medical Oncology 2023 Congress. He argued that Teliso-V’s safety profile could be a significant advantage, emphasizing the undesirable adverse events associated with competing therapies targeting EGFR mutants, including chemo-like effects such as nausea, vomiting, stomatitis, alopecia, and fatigue. According to Dr. Thakkar, achieving a delicate balance between efficacy and tolerability is crucial, and Teliso-V may offer a more favorable safety profile, addressing a critical need voiced by patients.

The post Lung Cancer Data from AbbVie Paves Way for Accelerated ADC Approval, Falls Below Initial Benchmark appeared first on LifeSci Voice.