AstraZeneca (AZ) and Daiichi Sankyo are eagerly awaiting a December verdict from the FDA regarding their potential therapy for lung cancer, datopotamab deruxtecan, marking the second drug in their antibody-drug conjugate (ADC) alliance. The FDA has initiated a review process for datopotamab deruxtecan, also known as Dato-DXd, with a decision expected by December 20th following a standard review.
Dato-DXd has been submitted for approval as a treatment for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have previously undergone systemic therapy. This TROP2-targeting drug falls into the same class as Trodelvy (sacituzumab govitecan) from Gilead Sciences, which is already approved by the FDA for several indications, including metastatic triple-negative breast cancer (TNBC) and metastatic urothelial cancer.
In the TROPION-Lung01 trial, Dato-DXd demonstrated a statistically significant improvement in progression-free survival (PFS) among NSCLC patients who had received at least one prior therapy, compared to treatment with docetaxel, a standard chemotherapy option for this patient population. Although data on overall survival (OS) is still pending maturity, there is a notable trend towards improvement.
The patient cohort in TROPION-Lung01 encompassed individuals with and without genomic alterations, suggesting that if approved by the FDA, Dato-DXd could receive a broad label, potentially serving as a second-line option after immunotherapies and drugs targeting specific mutations. Currently, patients in this category typically undergo conventional chemotherapy.
While Dato-DXd and Trodelvy initially target different cancers, there may soon be overlaps leading to direct competition between the two drugs. AZ and Daiichi Sankyo are conducting studies of their ADC in breast cancer, beginning with previously treated HR+/HER2- breast cancer patients in the TROPION-Breast01 trial, data from which has also been submitted to the FDA.
Concurrently, Trodelvy is undergoing evaluation in the phase 3 EVOKE-01 trial for relapsed NSCLC, although it did not meet its primary endpoint of improving OS. Nevertheless, Gilead is exploring a potential benefit in a subgroup of patients who did not respond to prior immunotherapy.
AZ obtained the rights to Dato-DXd in July 2020, entering into a significant licensing agreement with Daiichi Sankyo, valued at $1 billion upfront and up to $5 billion in regulatory and sales milestones. This agreement followed a previous deal between the two companies for Enhertu (trastuzumab deruxtecan), another HER2-directed ADC, worth $6.9 billion.
In addition to the developments with Dato-DXd, AZ recently reported results from the phase 3 LAURA trial of its EGFR inhibitor Tagrisso (osimertinib) in early-stage lung cancer, suggesting another potential regulatory filing for the drug. The trial compared Tagrisso to placebo after chemoradiotherapy (CRT) in patients with unresectable, stage 3 EGFR-mutated NSCLC. Top-line results showed a significant improvement in PFS, indicating a promising outcome for Tagrisso in this patient population.
These advancements underscore the potential of targeted therapies like Dato-DXd and Tagrisso to make a meaningful impact in the treatment landscape for lung cancer, with implications for patient care and management strategies.
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