While ESMO 2023 is just about to begin, potential pharma players such as Daiichi Sankyo, Pfizer, Mirati, Immutep, Merus, Merck and others are all geared up for presenting their NSCLC abstracts under oral and poster presentations session type. This content provides a brief summary on Lilly’s (Loxo Oncology) RETEVMO from LIBRETTO-431 clinical trial.

RET Fusion NSCLC Highlights

• Abstract Number – #LBA4
• Abstract Type – Proffered Paper Session
• Indication – NSCLC
• Target – RET Fusion-positive NSCLC

 

In the LIBRETTO-431 Phase III trial for treatment-naïve RET fusion-positive NSCLC, RETEVMO (selpercatinib) showcases a remarkable improvement in progression-free survival (PFS), with results meeting the primary endpoint, promising significant advancements in this field. Detailed findings will be unveiled at ESMO Congress 2023.

Main Content – LIBRETTO-431 is a randomized Phase III clinical trial of patients with treatment-naïve RET fusion-positive NSCLC. The trial enrolled 261 patients with advanced or metastatic RET fusion-positive NSCLC who had received no prior systemic therapy for metastatic disease. This trial's primary endpoint is PFS and secondary endpoints include overall survival (OS), overall response rate (ORR), duration of response (DoR), and intracranial ORR. For patients randomized to the control arm, crossover was allowed at progression.

The drug’s Phase III study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in PFS. Adverse events observed on RETEVMO were generally consistent with those identified across the previously reported development program.

It is the first FDA-approved treatment for people with RET-positive advanced NSCLC. The objective of the LIBRETTO-431 trial is to answer an important question about the selection of initial treatment for people with advanced RET fusion-positive NSCLC. The findings from the study strongly suggest that RETEVMO should be regarded as the preferred treatment option in newly diagnosed patients. Full results from LIBRETTO-431 pivotal Phase III trial will be presented at the ESMO Congress.

Note: The therapeutics segment is experiencing significant NSCLC clinical trial activity, which is further expected to drive Non-Small Cell Lung Caner market growth in the coming years.