AbbVie's Emrelis Secures FDA Approval for Lung Cancer, Advancing Solid Tumor Strategy

AbbVie has made significant strides in its oncology portfolio with the FDA's accelerated approval of Emrelis (telisotuzumab vedotin) for certain types of non-small cell lung cancer (NSCLC). This approval marks a pivotal moment for the company as it expands its presence in the solid tumor space and strengthens its position in the competitive antibody-drug conjugate (ADC) market.

Breakthrough in Lung Cancer Treatment

Emrelis has been approved for adult patients with locally advanced or metastatic non-squamous NSCLC who have high expression levels of the c-Met protein and have received prior systemic therapy. This makes it the first therapy specifically approved for this patient population, addressing a significant unmet need in lung cancer treatment.

The approval is based on data from the Phase II LUMINOSITY trial, which demonstrated an overall response rate (ORR) of 35% in patients with high c-Met expression. Patients with intermediate c-Met expression levels showed an ORR of 23%. The median duration of response was reported to be 7.2 months in the high c-Met expression subgroup.

Dr. Roopal Thakkar, AbbVie's Chief Scientific Officer, emphasized the significance of this approval, stating, "Emrelis can improve the course of treatment for patients facing this challenging disease."

Strategic Expansion in Oncology

The FDA nod for Emrelis represents a crucial step in AbbVie's broader oncology strategy. It is the company's first internally developed solid tumor drug to receive FDA approval in lung cancer, complementing its existing ADC portfolio, which includes Elahere for ovarian cancer, acquired through the $10.1 billion ImmunoGen acquisition earlier this year.

AbbVie has been actively expanding its oncology pipeline through strategic partnerships and acquisitions. Recent deals include:

• A potential $1.64 billion collaboration with Neomorph for molecular glue degraders in oncology and immunology
• A $2.1 billion agreement with Xilio Therapeutics for T cell therapies targeting the tumor microenvironment
• A partnership with ADARx, involving a $335 million upfront payment, to develop siRNA medicines for oncology, immunology, and neuroscience targets

Ongoing Clinical Development

While Emrelis has received accelerated approval, its continued approval may depend on further confirmatory studies. AbbVie is currently conducting the Phase III TeliMET NSCLC-01 study, which will serve as the confirmatory trial for Emrelis. This study is comparing the ADC to the chemotherapy docetaxel in patients with c-Met-overexpressing NSCLC.

The company is also leveraging the ongoing LUMINOSITY trial to identify NSCLC patient populations best suited for telisotuzumab as a second- or third-line monotherapy. This strategic approach aims to further validate the drug's efficacy across various metrics, including overall response rate, duration of response, disease control rate, progression-free survival, and overall survival.