AstraZeneca/Daiichi Sankyo Partnered Breast Cancer Drug Shows Survival Benefit Over Chemotherapy

AstraZeneca Plc (NASDAQ:AZN) and Daiichi Sankyo on Monday released high-level results from the TROPION-Breast02 Phase 3 trial.

The trial is evaluating Datroway (datopotamab deruxtecan) versus the investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin, or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for whom immunotherapy was not an option.

The trial included patients whose tumors did not express PD-L1 as well as patients with PD-L1 expressing tumors who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography.

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Data

Datroway demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to the investigator’s choice of chemotherapy as 1st-line treatment.

Approximately 70% of patients with metastatic TNBC are not candidates for immunotherapy, including all patients whose tumors do not express PD-L1, and patients with PD-L1-expressing tumors who cannot receive immunotherapy due to other factors.

Chemotherapy remains the 1st-line standard of care for these patients.

The safety profile of Datroway was consistent with previous clinical trials of Datroway in breast cancer.

AstraZeneca and Daiichi Sankyo are evaluating Datroway across stages and treatment settings of TNBC in three additional Phase 3 trials, including:

TROPION-Breast03 is evaluating Datroway with or without Imfinzi (durvalumab) in patients with Stage I-III TNBC with residual invasive disease after neoadjuvant systemic therapy.

TROPION-Breast04 is evaluating neoadjuvant Datroway plus Imfinzi in patients with Stage II-III triple-negative or hormone receptor (HR)-low, HER2-low or -negative breast cancer.

TROPION-Breast05 is evaluating 1st-line Datroway with or without Imfinzi in patients with metastatic TNBC whose tumors express PD-L1.

Datroway Background

In June, the Food and Drug Administration (FDA) granted accelerated approval for Datroway for adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer who have received prior EGFR-directed therapy and platinum-based chemotherapy.

In January, the FDA approved Datroway for adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

AZN Price Action: AstraZeneca shares were up 0.63% at $85.85 during premarket trading on Monday. The stock is trading at a new 52-week high, according to Benzinga Pro data.

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