Positive data for Enhertu in gastric cancer, breast cancer and NSCLC
AZ and Daiichi presented positive results from Enhertu trials at ESMO. In the primary analysis of DESTINY-Gastric02, the first trial of Enhertu in patients with HER2-positive metastatic gastric cancer or GEJ adenocarcinoma, Enhertu (6.4 mg/kg) demonstrated a confirmed ORR of 38%. Three (3.8%) complete responses (CR) and 27 (34.2%) partial responses (PR) were observed in patients treated with Enhertu. At a prespecified interim analysis of DESTINY-Breast03, Enhertu demonstrated a 72% reduction in the risk of disease progression or death compared to T-DM1.
After 15.5 and 13.9 months of follow-up in the Enhertu and T-DM1 arms respectively, the median PFS for patients treated with Enhertu was not reached compared to 6.8 months for T-DM1. Primary results from the HER2m cohort (cohort 2) of DESTINY-Lung01 in previously treated HER2m NSCLC demonstrated a confirmed objective response rate (ORR) of 54.9% in patients treated with Enhertu (6.4 mg/kg) as assessed by independent central review (ICR). One (1.1%) complete response (CR) and 49 (53.8%) partial responses (PR) were observed.
Clinical trial explores new FRα-targeting ADC for platinum-resistant ovarian cancer
The advances observed with STRO-002 include a Fast Track designation granted by the FDA in August 2021 for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 prior lines of systemic therapy. This announcement came shortly after early signals of efficacy were shown in 34 patients treated in a phase 1 clinical trial (NCT03748186) with STRO-002 at 2.9 mg/kg or higher. In 31 evaluable patients, treatment with STRO-002 led to responses in 10 patients, including 1 complete response and 9 partial responses (PRs). At the time of data cutoff, there were also 6 patients with unconfirmed PRs. The disease control rate was 74%.
STRO-002 also showed early signs of tolerability in the phase 1 study. Grade 1 or 2 treatment-emergent adverse events (TEAEs) occurred in 86% of patients. No ocular toxicity had occurred by the data cutoff date, but prophylactic corticosteroid eye drops had been administered to patients. The most common grade 3/4 TEAE was neutropenia, which was reversible. Standard medication was also administered to the 15.4% of patients who experienced grade 3 arthralgia and the 7.7% who experienced neuropathy.