AbbVie Secures FDA Approval for Novel Lung Cancer ADC, Advancing Solid Tumor Strategy

AbbVie has achieved a significant milestone in its oncology portfolio with the FDA's accelerated approval of Emrelis (telisotuzumab vedotin), a c-Met-directed antibody-drug conjugate (ADC) for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). This approval marks AbbVie's first internally developed solid tumor drug to receive FDA clearance in lung cancer, solidifying the company's position in the competitive ADC market.

Emrelis: A Precision Approach to Lung Cancer Treatment

Emrelis targets patients with high c-Met protein overexpression who have previously received systemic therapy. The c-Met protein is overexpressed in approximately 25% of patients with advanced epidermal growth factor receptor wild-type, non-squamous NSCLC, with about half of these patients exhibiting high c-Met overexpression.

The FDA's decision was based on data from the phase 2 Luminosity study, where Emrelis demonstrated a 35% overall response rate (ORR) and a median duration of response (DOR) of 7.2 months in c-Met-high patients. Dr. Roopal Thakkar, AbbVie's chief scientific officer, emphasized the significance of this approval, stating that Emrelis represents the company's first internally developed solid tumor drug to win FDA approval in lung cancer.

AbbVie's Growing ADC Portfolio and Solid Tumor Strategy

The approval of Emrelis comes on the heels of AbbVie's recent acquisition of ImmunoGen for $10.1 billion, which added the ovarian cancer ADC Elahere to its commercial portfolio. This strategic move, coupled with the Emrelis approval, underscores AbbVie's commitment to establishing a strong presence in solid tumor treatments.

AbbVie executives have previously highlighted their focus on ADCs, particularly in solid tumors. Dr. Daejin Abidoye, head of solid tumors in oncology development at AbbVie, noted the significant shift of ADCs from primarily hematology applications to playing a crucial role in solid tumors over the past five years.

The company's pipeline includes several other ADC candidates, such as ABBV-706 for small cell lung cancer and ABBV-400 for colorectal cancer, further demonstrating AbbVie's dedication to expanding its oncology offerings.

Looking Ahead: Confirmatory Trials and Market Potential

As part of the accelerated approval process, AbbVie is conducting a phase 3 confirmatory study, TeliMET NSCLC-01, comparing Emrelis to the chemotherapy docetaxel. This study aims to further validate the efficacy of Emrelis across various metrics, including ORR, DOR, disease control rate, progression-free survival, and overall survival.

The market reception for Emrelis appears promising, with a recent ZoomRx survey indicating high awareness and anticipation among oncologists. The survey, conducted in June, revealed that 55% of oncologists were aware of AbbVie's drug, with nearly one-quarter naming telisotuzumab as one of the three most exciting cancer prospects in development. Additionally, almost one-third of oncologists viewed telisotuzumab as a potential game-changer, with approximately 25% indicating they would prescribe the AbbVie ADC.