AstraZeneca :Dato-DXd Fails To Significantly Improve Overall Survival In Phase III Lung Cancer Trial

(RTTNews) - AstraZeneca (AZN.L, AZN) and Daiichi Sankyo's (DSKYF.PK) datopotamab deruxtecan (Dato-DXd) did not significantly improve overall survival for adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer, according to detailed results from the TROPION-Lung01 Phase III trial.

Jacob Sands, MD, Dana-Farber Cancer Institute, Medical Oncology and investigator in the trial, said: "Despite many efforts to surpass docetaxel with novel approaches in previously treated advanced or metastatic non-small cell lung cancer, patients only survive for about one year.

The TROPION-Lung01 Phase III trial evaluated AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan compared to docetaxel, the current standard of care chemotherapy, in adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who had received at least one prior line of therapy.

Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed by AstraZeneca and Daiichi Sankyo.

In the overall trial population, overall survival results numerically favoured datopotamab deruxtecan compared to docetaxel (12.9 versus 11.8 months) but did not reach statistical significance, according to the companies.

In the prespecified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a 2.3-month improvement in overall survival compared to docetaxel (14.6 versus 12.3 months; HR 0.84; 95% CI 0.68-1.05).

Meanwhile, AstraZeneca and Daiichi Sankyo noted that results from the NeoCOAST-2 Phase II platform trial evaluating Imfinzi (durvalumab) in multiple novel combinations, before and after surgery, in patients with early-stage (Stage IIA-IIIB) resectable NSCLC were featured in a WCLC Presidential Symposium.

Preliminary results from the trial arm testing neoadjuvant Imfinzi plus datopotamab deruxtecan and carboplatin demonstrated a pathological complete response rate of 34.1% and a major pathological response rate of 65.9%. This was numerically higher than the response rates shown by other combination regimens tested, however, the trial was not powered to make direct statistical comparisons between arms, the companies said.

The safety profile of Imfinzi plus datopotamab deruxtecan and carboplatin was consistent with the known safety profiles of these agents. Surgical rates across arms were comparable and in line with those shown in recent Phase III trials. AstraZeneca and Daiichi Sankyo are evaluating datopotamab deruxtecan in combination with Imfinzi in multiple ongoing trials.

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