Datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum-based chemotherapy showed promising clinical activity and no new safety signals in both previously untreated and pretreated patients with advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations, according to initial data from a recent trial conducted by Tokyo-based Daiichi Sankyo and global pharmaceutical giant AstraZeneca.

Announcing the results, the companies stated recently their datopotamab deruxtecan plus pembrolizumab with or without platinum chemotherapy achieved objective response rates of 57% and 50%, respectively, with a disease control rate of 91% across cohorts in previously untreated patients.

Both companies stated that these data would be shared during an oral presentation at the American Society of Clinical Oncology Annual Meeting (ASCO23).

The drug jointly developed by Daiichi Sankyo and AstraZeneca is a precisely engineered TROP2-directed DXd antibody-drug conjugate.

Pointing out that over one million people across the globe are diagnosed with advanced NSCLC each year, the statement added that while first-line treatment with immune checkpoint inhibitors improves outcomes initially, most of them eventually experience disease progression.

Although TROP2 is expressed in more than 90% of NSCLC tumours, the companies said that no TROP2-directed ADCs are currently licenced for lung cancer treatment.

Commenting on the development, Dr Yasushi Goto of the Division of Internal Medicine and Thoracic Oncology at Tokyo’s National Cancer Center Hospital said, “Nearly all patients with advanced non-small cell lung cancer experience disease progression following initial therapy, underscoring the need for novel therapeutic approaches across treatment lines.”

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“The updated results from TROPION-Lung02 signal the potential for datopotamab deruxtecan combinations to improve outcomes for patients with non-small cell lung cancer and are a promising development in pursuing a new standard treatment option beyond immunotherapy,” he added.

“We continue to be encouraged by the findings from TROPION-Lung02, the first trial to evaluate the combination of a TROP2-directed antibody-drug conjugate and an immune checkpoint inhibitor with or without platinum chemotherapy in patients with advanced non-small cell lung cancer,” Dr Mark Rutstein,  the Global Head of Oncology Clinical Development at Daiichi Sankyo said.

“These data, alongside previous results for datopotamab deruxtecan combined with an immune checkpoint inhibitor, reinforce the potential of these combinations to improve outcomes for patients with different advanced cancers,” he added.

“With more patients and nearly a year of additional follow-up, the updated TROPION-Lung02 results show that datopotamab deruxtecan continues to elicit promising and durable responses in a diverse subset of patients with non-small cell lung cancer,” Chief Medical Officer and Chief Development Officer of Oncology at AstraZeneca Dr Cristian Massacesi said.

He expressed confidence that the early data could lead to the combination being recognised as a first-line treatment option for patients with advanced lung cancer.