The OncFive: Top Oncology Articles for the Week of 12/8

Welcome to OncLive®’s OncFive! Every week, we will compile the top 5 stories in oncology, ranging from pivotal regulatory decisions to news updates and expert interviews spanning tumor types.

Here’s what you may have missed this week:

Fixed-Duration Acalabrutinib/Venetoclax Combo Improves PFS in Frontline CLL

Data from an interim analysis of the phase 3 AMPLIFY trial (NCT03836261) showed that the combination of acalabrutinib (Calquence) and venetoclax (Venclexta) with or without obinutuzumab (Gazyva) significantly improved progression-free survival (PFS) over standard chemoimmunotherapy in patients with treatment-naive chronic lymphocytic leukemia (HR, 0.65; 95% CI, 0.39-0.87; P = .0038). At a median follow-up of 40.8 months, the median PFS was not reached (NR) with acalabrutinib plus venetoclax and acalabrutinib plus venetoclax/obinutuzumab vs 47.6 months with investigator’s choice of fludarabine plus cyclophosphamide and rituximab (Rituxan) or bendamustine plus rituximab.

Daratumumab Significantly Improves PFS, Extends OS in Smoldering Myeloma

Primary data from the phase 3 AQUILA study (NCT03301220) showed that subcutaneous daratumumab (Darzalex Faspro) significantly boosted PFS and extended overall survival (OS) vs active monitoring in patients with intermediate- or high-risk smoldering multiple myeloma (HR, 0.49; 95% CI, 0.36-0.67; P < .001). At a median follow-up of 65.2 months, the median PFS was NR with subcutaneous daratumumab vs 41.5 months with active monitoring. The respective PFS rates at 60 months were 63.1% and 40.8%. The 60-month OS rates in the daratumumab and active monitoring arms were 93.0% and 86.9%, respectively (HR, 0.52; 95% CI, 0.27-0.98).

Check out more coverage from the 2024 ASH Annual Meeting.

Imlunestrant With or Without Abemaciclib Boosts PFS in ESR1+, ER+/HER2– Advanced Breast Cancer

Findings from the phase 3 EMBER-3 study (NCT04975308) showed that treatment with imlunestrant (LY3484356) significantly improved PFS over standard-of-care endocrine therapy in patients with estrogen receptor–positive, HER2-negative advanced breast cancer harboring ESR1 mutations whose disease progressed on previous endocrine treatment. The median PFS with single-agent imlunestrant (n = 138) was 5.5 months (95% CI, 3.9-7.4) vs 3.8 months (95% CI, 3.7-5.5) with endocrine therapy (n = 118; HR, 0.62; 95% CI, 0.46-0.82; P < .001). The median PFS with imlunestrant plus abemaciclib (Verzenio; n = 213) was 9.4 months (95% CI, 7.5-11.9) vs 5.5 months (95% CI, 3.8-5.6) with imlunestrant alone (n = 213; HR, 0.57; 95% CI, 0.44-0.73; P < .001).

Camrelizumab/Chemo Could Represent New Neoadjuvant Option in Early or Locally Advanced TNBC

Findings from the phase 3 CamRelief study (NCT04613674) showed that neoadjuvant camrelizumab paired with intensive chemotherapy (n = 222) boosted pathologic complete response (pCR) rates vs chemotherapy alone (n = 219) in patients with early or locally advanced triple-negative breast cancer. The respective pCR rates were 56.8% and 44.7%, translating to a 12.2% percentage difference between the arms (95% CI, 3.3%-21.2%; 1-sided P = .0038). Early trends in event-free survival (HR, 0.80; 95% CI, 0.46-1.42; P = .224), disease-free survival (HR, 0.58; 95% CI, 0.27-1.24; P = .0784), and distant disease-free survival (HR, 062; 95% CI, 0.29-1.33; P = .107) complemented the pCR benefit observed with camrelizumab plus chemotherapy.

Check out more coverage from 2024 San Antonio Breast Cancer Symposium.

FDA Grants Breakthrough Therapy Designation to Dato-DXd for Previously Treated EGFR+ NSCLC

The regulatory agency granted breakthrough therapy designation to datopotamab deruxtecan for use in adult patients with locally advanced or metastatic, EGFR-mutated non–small cell lung cancer with disease progression on or following treatment with an EGFR TKI and platinum-based chemotherapy. The decision was supported by findings from the phase 2 TROPION-Lung 05 (NCT04484142) and the phase 3 TROPION-Lung01 (NCT04656652) trials. Data from a pooled analysis of those treated in -Lung05 (n = 78) and -Lung-01 (n = 39) showed that the agent elicited an objective response rate of 42.7% (95% CI, 33.6%-52.2%) by blinded independent central review.