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Adjuvant ribociclib receives FDA approval for HR+ breast cancer, AMG 193 elicits responses in MTAP-deleted solid tumors, and more this week from OncLive.
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:
FDA Approves Adjuvant Ribociclib in HR+/HER2– Breast Cancer
On September 17, 2024, the regulatory agency approved the selective cyclin-dependent kinase inhibitor, ribociclib (Kisqali), paired with an aromatase inhibitor for the adjuvant treatment of patients with hormone receptor–positive, HER2-negative stage II and III early breast cancer at high risk of recurrence, including those with node-negative disease. The decision was supported by findings from the phase 3 NATALEE trial (NCT03701334) in which the regimen significantly improved invasive disease-free survival (iDFS) vs endocrine therapy alone (HR, 0.749; 95% CI, 0.628-0.892; P = .0006). The iDFS benefit achieved with the ribociclib combination proved consistent across all patient subgroups analyzed.
AMG 193 Shows Preliminary Clinical Activity in MTAP-Deleted Solid Tumors
The MTA-cooperative PRMT5 inhibitor, AMG 193, elicited responses when given at active doses of 800 mg daily, 1200 mg daily, and 600 mg twice daily (n = 76) and showcased an acceptable toxicity profile in patients with MTAP-deleted solid tumors, according to data from a phase 1 trial (NCT05094336) were shared during the 2024 ESMO Congress. Presenting study author Adrian Sacher, MD, a thoracic oncologist and affiliate scientist of Princess Margaret Cancer-Centre of the University of Toronto in Toronto, Ontario, Canada, said “AMG 193 … represents a novel class of targeted therapeutics designed to induce synthetic lethality in MTAP-deleted solid tumors while sparing normal tissue.”
On September 17, 2024, the FDA gave the green light to pembrolizumab (Keytruda) in combination with pemetrexed and platinum chemotherapy in the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma based on findings from the phase 2/3 KEYNOTE-483 study (NCT02784171). The pembrolizumab combination (n = 222) led to a median overall survival (OS) of 17.3 months (95% CI, 14.4-21.3) vs 16.1 months (95% CI, 13.1-18.2) with chemotherapy alone (HR, 0.79; 95% CI, 0.64-0.98; P = .0162). The pembrolizumab combination also reduced the risk of disease progression or death by 20% (HR, 0.80; 95% CI, 0.65-0.99; P = .0194).
Neoadjuvant Pembrolizumab/Chemo, Adjuvant Pembrolizumab Boosts OS in Early TNBC
Data from the phase 3 KEYNOTE-522 trial (NCT03036488) were also shared during the 2024 ESMO Congress and showed that neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab (n = 784) resulted in a 34% reduction in the risk of death vs neoadjuvant chemotherapy followed by adjuvant placebo (n = 390) in patients with early-stage triple-negative breast cancer (HR, 0.66; 95% CI, 0.50-0.87; P = .00150). At a median follow-up of 75.1 months, the respective 5-year OS rates were 86.6% (95% CI, 84.0%-88.8%) and 81.7% (95% CI, 77.5%-85.2%).
Experts Highlight Top Findings From the 2024 IASLC World Conference on Lung Cancer
Lung cancer experts sat down with OncLive® to discuss the most notable takeaways from the 2024 IASLC World Conference on Lung Cancer. The recap includes insights from Alexander Spira, MD, PhD, FACP, of Virginia Cancer Specialists and The US Oncology Network; Li Zhang, MD, of Sun Yat-sen University Cancer Center; T. Jeroen N. Hiltermann, MD, of the University of Gronigen; Natasha B. Leighl, BSc, MMSc, MD, of Princess Margaret Cancer Centre; Tina Cascone, MD, PhD, of The University of Texas MD Anderson Cancer Center; Triparna Sen, PhD, of Icahn School of Medicine at Mount Sinai; and more.