Recent data from the 2016 American Society of Clinical Oncology (ASCO) annual meeting have shown that rovalpituzumab tesirine (Rova-T), AbbVie's antibody-drug conjugate (ADC) to treat recurrent/refractory small cell lung cancer (SCLC), represents a promising new approach, as it is the first biomarker-directed therapy for treating the disease, according to an analyst with research and consulting firm GlobalData.

SCLC is an aggressive form of lung cancer that accounts for approximately 15% of all lung cancers.

As explored in GlobalData's most recent small cell lung cancer report, there is an urgent need for effective therapies in the disease, as the currently available treatment options remain limited.

Dr Volkan Gunduz, GlobalData's Analyst covering Oncology & Hematology, explains: "By attaching a powerful chemotherapy that is too potent to administer on its own to an antibody that detects delta-like protein 3 (DLL3), Rova-T delivers the payload directly to cancer cells. Importantly, DLL3 is not present in healthy tissue but is expressed in more than 80% of SCLC patient tumors, making it a highly specific biomarker for SCLC."

The most promising aspect of data from the Phase I/II trial is the discovery of a biomarker that could predict the efficacy of a targeted therapy for treating SCLC.

In 74 patients enrolled in this trial, 88% had DLL3 expression on ≥1% of tumor cells, meaning that majority of the patients with SCLC may benefit from this therapy.

Dr Gunduz continues: "AbbVie has an ambitious clinical program for Rova-T and has already initiated the potentially registrational Phase II TRINITY trial investigating the efficacy of Rova-T as a third-line treatment in DLL3-expressing SCLC. The preliminary results of this trial could serve as the basis for an FDA approval in 2017, making Rova-T the first targeted drug ever approved for SCLC.

"As this is an indication with high unmet need that has no currently approved third-line therapies, GlobalData expects Rova-T will be a strong revenue booster for AbbVie, helping to offset the patent expiry of its top-selling anti-inflammatory drug, Humira (adalimumab), in the last quarter of 2016."

GlobalData estimates that the SCLC market across the seven major markets of the US, France, Germany, Italy, Spain, the UK, and Japan was worth $198 million in 2014 and will expand rapidly to reach $2.29 billion by 2024.