Daiichi Sankyo secures NSCLC breakthrough designation

The FDA has granted breakthrough therapy designation to Daiichi Sankyo for datopotamab deruxtecan, an antibody-drug conjugate (ADC) aimed at treating non-small cell lung cancer (NSCLC). This designation is specifically for patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) NSCLC. This decision is based on promising early results from the ongoing TROPION-Lung05 Phase II trial.

The TROPION-Lung05 trial is a randomized, multicenter, open-label study involving 137 patients across Asia, Europe, and North America. The trial aims to evaluate the effectiveness and safety of this ADC in patients with advanced NSCLC who have previously undergone treatment. The early results showed a significant tumor response, leading the FDA to grant the breakthrough designation, which is designed to hasten the approval process for drugs that address serious conditions and meet critical medical needs.

Daiichi Sankyo developed this ADC in collaboration with AstraZeneca. The early findings from the TROPION-Lung05 trial were presented at the European Society of Medical Oncology (ESMO) Asia 2024 Congress. Alongside these findings, results from a parallel Phase III trial, TROPION-Lung01, were also shared. The TROPION-Lung01 trial is comparing the efficacy and safety of datopotamab deruxtecan to docetaxel in treating NSCLC.

Ken Takeshita, Daiichi Sankyo's global head of research and development, emphasized the importance of this breakthrough designation. He noted the significant unmet needs for new treatments for patients with previously treated EGFR-mutated NSCLC who have experienced disease progression. Takeshita expressed optimism about the potential of datopotamab deruxtecan to improve patient outcomes and highlighted the company's commitment to working with the FDA to expedite the availability of this treatment.

Breakthrough therapy designations are intended to speed up the development and review process for drugs that treat serious conditions and offer significant advantages over existing treatments. This designation for datopotamab deruxtecan underscores its potential as a promising therapy for lung cancer patients who have limited options after disease progression.

Susan Galbraith, vice president of oncology research and development at AstraZeneca, reiterated the significance of this designation. She highlighted the continued unmet needs of patients with EGFR-mutated lung cancer and noted AstraZeneca's long-standing commitment to supporting this patient community. Galbraith expressed hope that datopotamab deruxtecan could become a valuable new treatment option for these patients.

In a related development, speakers at an oncology conference in Munich emphasized the need for cancer researchers to effectively utilize real-world data. This is crucial to prevent NSCLC trials from failing due to issues like patient burnout and misallocated resources. The effective use of real-world data can help optimize trial designs and ensure better resource allocation, ultimately improving the success rates of clinical trials.

In summary, the FDA's breakthrough therapy designation for datopotamab deruxtecan marks a significant step forward in the treatment of EGFR-mutated NSCLC. The promising early results from the TROPION-Lung05 trial and the ongoing research efforts underscore the potential of this ADC to address a critical unmet need in lung cancer treatment. Both Daiichi Sankyo and AstraZeneca are committed to advancing this therapy to improve outcomes for patients facing limited treatment options.