Daiichi Sankyo and AstraZeneca's TROP2 ADC Datopotamab Deruxtecan Receives FDA Approval for EGFR-Mutated NSCLC

On June 23, Daiichi Sankyo and AstraZeneca announced: Derdatomab（Datopotamab deruxtecan）Has received FDA approval in the United States for the second indication, used to treat locally advanced or metastatic cases that have previously undergone EGFR-targeted therapy and platinum-based chemotherapy.EGFR Mutation Non-Small Cell Lung Cancer (NSCLC) Adult Patients。

The press release noted that this approval has made DebdumabThe First TROP2-Targeted Therapy Approved by the FDA for Previously Treated Advanced EGFR-Mutated NSCLC Patients. This approval also means that AstraZeneca will pay Daiichi Sankyo a milestone payment of 45 million US dollars.

Screenshot source: Corporate official website

Datozumab is a DXd ADC targeting TROP2, initially developed by Daiichi Sankyo. In July 2020, Daiichi Sankyo and AstraZeneca entered into a collaboration worth over $6 billion globally.(Excluding Japan)Co-develop and commercialize Databotumab, which is the second collaboration in the ADC field after the HER2 ADC Trastuzumab Deruxtecan.

In January this year, the FDA approved Dabotumab.First IndicationLaunched for the treatment of patients who have previously received endocrine therapy and chemotherapy.HR-positive, HER2-negative unresectable or metastatic breast cancer adult patients。

The approval of this new indication is based on the subgroup results from the TROPION-Lung05 Phase II and TROPION-Lung01 Phase III trials, for which the FDA previously granted datopotamab deruxtecan priority review and Breakthrough Therapy Designation based on data from these two studies.

TROPION-Lung05 is a global, multicenter, single-arm, open-label Phase II clinical trial designed to evaluate the efficacy and safety of datopotamab deruxtecan in patients with locally advanced or metastatic NSCLC. TROPION-Lung01 is a global, randomized, multicenter, open-label Phase III clinical trial designed to assess the efficacy and safety of datopotamab deruxtecan compared to docetaxel in adult patients with locally advanced or metastatic NSCLC.

In the TROPION-Lung05 and TROPION-Lung01 trials, datopotamab deruxtecan demonstrated efficacy in 114 patients with locally advanced or metastatic EGFR-mutated NSCLC previously treated and evaluated by BICR.Confirmed Objective Response Rate (ORR) For 45%(95% Confidence Interval [CI]: 35-54)4.4% of patients achieved complete remission. (CR), 40% of patients achieved partial remission (PR)。Median Duration of Response(DoR) For 6.5 months（95% CI：4.2-8.4）。

In a study involving 125 patients with locally advanced or metastatic EGFR mutations who were treated with datopotamab deruxtecan in the TROPION-Lung05, TROPION-Lung01, and TROPION-PanTumor01 trials NSCLC In the pooled analysis of patients, researchers evaluated Datopotamab Deruxtecan.(6 mg/kg) Safety:

• The most common (≥20%) adverse reactions include stomatitis, nausea, alopecia, fatigue, decreased hemoglobin, lymphopenia, constipation, hypercalcemia, increased aspartate aminotransferase, decreased white blood cell count, increased lactate dehydrogenase, musculoskeletal pain, decreased appetite, increased alanine aminotransferase, and rash.

• 26% of patients in the Derdatomab group experienced serious adverse reactions. Serious adverse reactions that occurred in more than 1% of patients in the Derdatomab group included COVID-19, stomatitis, and pneumonia.

For patients with advanced EGFR-mutant lung cancer who have previously received targeted therapy and chemotherapy, controlling disease progression is extremely challenging due to the limited options for later-line treatments. The approval of Datopotamab Deruxtecan in the United States offers a novel treatment option for patients with advanced lung cancer.

Daiichi Sankyo and AstraZeneca are evaluating the efficacy of DATROWAY as a monotherapy and/or in combination with AstraZeneca's EGFR tyrosine kinase inhibitor osimertinib for the treatment of other advanced or metastatic EGFR-mutated non-small cell lung cancer in the TROPION-Lung14 and TROPION-Lung15 Phase III clinical trials.

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Editor：Fragrant Medicine

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