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Trastuzumab Deruxtecan Shows Clinically Meaningful Response in Non-Small Cell Lung Cancer

Trastuzumab deruxtecan produces a confirmed objective response rate of 53.8% and 42.9% in the 5.4 mg/kg arm and 6.4 mg/kg treatment arms, respectively, among patients with HER2 mutant non-small cell lung cancer.

Trastuzumab deruxtecan (Enhertu; AstraZeneca, Daiichi Sankyo) demonstrated clinically meaningful tumor responses in previously treated patients with human epidermal growth factor receptor 2 mutant (HER2m) unresectable and/or metastatic non-squamous non­–small cell lung cancer (NSCLC), according to detailed positive results from an interim analysis of the DESTINY-Lung02 phase 2 trial. The results of the trial were presented as a late-breaking presentation at the European Society for Medical Oncology (ESMO) Congress 2022.

ā€œThe DESTINY-Lung02 results are consistent with the data previously seen withĀ [trastuzumab deruxtecan] in [NSCLC] and the efficacy demonstrated in this interim analysis, which supported the recent US FDA accelerated approval ofĀ [trastuzumab deruxtecan] in patients with HER2[m] [NSCLC], reinforces the potential to establish this medicine as a treatment option for these patients. These data will help inform future regulatory submissions worldwide with the goal of continuing to offer this innovative medicine to as many patients as possible,ā€ Ken Takeshita, MD, global head of research and development at Daiichi Sankyo, said in a statement.

Trastuzumab deruxtecan is a specifically engineered HER2-directed antibody drug conjugate. At the pre-specified interim analysis of DESTINY-Lung02, individuals administered trastuzumab deruxtecan at a dose of 5.4 mg/kg or 6.4 mg/kg demonstrated meaningful activity.

Investigators found a confirmed objective response rate of 53.8% and 42.9% in the 5.4 mg/kg arm and 6.4 mg/kg arm, respectively. Additionally, there was 1 complete response observed in each arm, with 27 partial responses in the 5.4 mg/kg arm and 11 in the 6.4 mg/kg arm.

ā€œDESTINY-Lung02 reinforces HER2 as an actionable mutation in patients with metastatic [NSCLC] and further demonstrates that [trastuzumab deruxtecan] provides a clinically meaningful tumor response for these patients who have historically had limited treatment options. The response seen in this trial, along with the disease control observed support [trastuzumab deruxtecan] as a potential treatment option in this type of [NSCLC],ā€ Koichi Goto, MD, a medical oncologist and investigator at the National Cancer Center Hospital East in Kashiwa, Japan, said in a statement.

At the pre-specified interim analysis, a median duration of response (DoR) was not reached in the 5.4 mg/kg arm and was 5.9 months in the 6.4 mg/kg arm. Due to the median DoR not being reached in the 5.4 mg/kg arm, an additional 90-day follow-up response analysis was conducted.

Investigators found that [trastuzumab deruxtecan] demonstrated a confirmed ORR of 57.7% and a median DoR of 8.7 months, with a complete response in 1.9% of individuals and partial responses in 55.8% of individuals. Furthermore, investigators observed a favorable safety profile for the 5.4 mg/kg arm with no safety signals identified at either dose.

The most common treatment-related adverse events grade 3 or higher were anemia, leukopenia, and neutropenia. The safety profile for both doses was also consistent with the overall safety profile of trastuzumab deruxtecan. Further, the 5.4 mg/kg dose demonstrated a favorable safety profile for this patient population.

Reference

DESTINY-Lung02 phase II trial shows clinically meaningful efficacy and favorable safety at 5.4mg/kg vs. 6.4mg/kg dose of AstraZeneca and Daiichi Sankyo’s Enhertu in HER2-mutant disease. News release. AstraZeneca. September 11, 2022. Accessed September 12, 2022. https://www.astrazeneca.com/media-centre/press-releases/2022/enhertu-continues-to-demonstrate-clinically-meaningful-tumour-response-in-patients-with-her2-mutant-metastatic-non-small-cell-lung-cancer.html

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