AstraZeneca's Investigational Cancer Drug Disappoints In Late-Stage Lung Cancer Trial

Monday, AstraZeneca Plc AZN shared detailed results from the TROPION-Lung01 Phase 3 of datopotamab deruxtecan (Dato-DXd) compared to docetaxel, the current standard of care chemotherapy for locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) treated with at least one prior line of therapy.

Detailed results showed a clinically meaningful trend toward improving overall survival (OS) with datopotamab deruxtecan (Dato-DXd) compared to docetaxel.

Also Read: AstraZeneca In Trouble For Employee Detentions in China Over Illegal Activities.

Dato-DXd is an engineered TROP2-directed DXd antibody-drug conjugate discovered by Daiichi Sankyo Ltd DSKYF DSNKY and being jointly developed by AstraZeneca and Daiichi Sankyo.

In the overall trial population, OS results numerically favored datopotamab deruxtecan compared to docetaxel (12.9 vs. 11.8 months) but did not reach statistical significance (hazard ratio [HR] 0.94; p=0.530).

In the prespecified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a 2.3-month improvement in OS compared to docetaxel (14.6 vs. 12.3 months).

The safety profile of datopotamab deruxtecan in TROPION-Lung01 was consistent with the previous analysis, including lower rates of dose reduction (20%, 30%) and discontinuation (8%, 12%) due to adverse events compared to docetaxel.

At the World Conference on Lung Cancer (WCLC), the British pharma giant shared results from the NeoCOAST-2 Phase 2 platform trial of Imfinzi (durvalumab) in multiple combinations, before and after surgery, in patients with early-stage (Stage IIA–IIIB) resectable NSCLC.

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%.

Recently, the FDA approved AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy for adult patients with resectable early-stage NSCLC and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.

Price Action: AZN stock is down 1.16% at $79.95 during the premarket session at last check Tuesday.

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