Originally published by our sister publication Clinical Oncology News

By Clinical Oncology News Staff

The FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.

Efficacy was evaluated in 192 adult patients with previously treated unresectable or metastatic HER2-positive (IHC 3+) solid tumors who were enrolled in one of three multicenter trials: DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02. All three trials excluded patients with a history of interstitial lung disease (ILD)/pneumonitis requiring treatment with steroids or ILD/pneumonitis at screening and clinically significant cardiac disease. Patients were also excluded for active brain metastases or Eastern Cooperative Oncology Group performance status greater than one. Treatment was administered until disease progression, death, withdrawal of consent, or unacceptable toxicity.

The major efficacy outcome measure in all three trials was confirmed objective response rate (ORR), and an additional efficacy outcome was duration of response (DOR). All outcomes were assessed by independent central review (ICR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). In DESTINY-PanTumor02, ORR was 51.4% (95% CI, 41.7%- 61.0%) and median DOR was 19.4 months (range, 1.3-27.9+ months). In DESTINY-Lung01, ORR was 52.9% (95% CI, 27.8%-77.0%) and median DOR was 6.9 months (range, 4.0-11.7+ months). In DESTINY-CRC02, ORR was 46.9% (95% CI, 34.3%-59.8%), and DOR was 5.5 months (range, 1.3+ - 9.7+ months).

The most common adverse reactions (≥20%), including laboratory abnormalities, were decreased white blood cell count, nausea, decreased hemoglobin, decreased neutrophil count, fatigue, decreased lymphocyte count, decreased platelet count, increased aspartate aminotransferase, increased alanine aminotransferase, increased blood alkaline phosphatase, vomiting, decreased appetite, alopecia, diarrhea, decreased blood potassium, constipation, decreased sodium, stomatitis, and upper respiratory tract infection. The prescribing information includes a boxed warning advising health professionals of the risk of interstitial lung disease and embryo-fetal toxicity.

Full prescribing information for Enhertu is posted here.

Based on a press release from the FDA.