The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.
Tisotumab Vedotin Improves Survival in Recurrent/Metastatic Cervical Cancer
October 22nd 2023Tisotumab vedotin led to a 30% reduction in the risk of death vs investigator’s choice of chemotherapy as second- or third-line therapy in patients with recurrent or metastatic cervical cancer with disease progression on doublet chemotherapy.
Frontline Nivolumab Plus Chemotherapy Boosts OS and PFS in Metastatic Urothelial Carcinoma
October 22nd 2023Concurrent frontline nivolumab and gemcitabine-cisplatin followed by nivolumab maintenance therapy elicited OS and PFS benefits vs gemcitabine-cisplatin alone in patients with previously untreated, metastatic or unresectable urothelial carcinoma.
Niraparib Plus Abiraterone and Prednisone Elicits OS Benefit in BRCA1/2+ mCRPC
October 22nd 2023The addition of niraparib to abiraterone acetate and prednisone led to a benefit in overall survival vs treatment with AAP alone in patients with BRCA1/2-mutated metastatic castration-resistant prostate cancer.
Osimertinib Plus Chemo Improves CNS PFS in EGFR+ Advanced NSCLC With Baseline Brain Metastases
October 21st 2023Osimertinib plus chemotherapy reduced the risk of central nervous system disease progression or death vs osimertinib alone in patients with locally advanced or metastatic EGFR-positive non–small cell lung cancer who had brain metastases at baseline, according to data from the phase 3 FLAURA2 trial.
Selpercatinib Significantly Improves PFS, Responses in Advanced RET+ Medullary Thyroid Cancer
October 21st 2023Selpercatinib resulted in a statistically significant improvement in progression-free survival and overall response rate compared with cabozantinib or vandetanib in patients with advanced, multikinase inhibitor–naïve, RET-mutant medullary thyroid cancer, according to interim findings from the phase 3 LIBRETTO-531 trial.
Maintenance Durvalumab Plus Olaparib Improves PFS in Advanced or Recurrent Endometrial Cancer
October 21st 2023The addition of durvalumab to first-line chemotherapy, followed by maintenance treatment with durvalumab plus olaparib significantly improved progression-free survival in patients with newly diagnosed advanced or recurrent endometrial cancer, according to data from the phase 3 DUO-E/GOG-3041/ENGOT-EN10 trial.
Perioperative Nivolumab Significantly Improves EFS in Previously Untreated Resectable NSCLC
October 21st 2023Neoadjuvant treatment with nivolumab plus chemotherapy followed by surgery and adjuvant nivolumab resulted in a statistically significant improvement in event-free survival vs placebo plus chemotherapy, in patients with previously untreated resectable stage II to IIIB non-small cell lung cancer, according to data from the phase 3 CheckMate 77T trial.
Trastuzumab Deruxtecan Sustains Survival Benefits in HER2-Low Metastatic Breast Cancer
October 21st 2023Treatment with fam-trastuzumab deruxtecan-nxki led to sustained improvements in overall survival and progression-free survival vs physician’s choice of treatment in patients with previously treated HER2-low metastatic breast cancer, irrespective of hormone receptor status.
Belzutifan Plus Cabozantinib Delivers Durable Responses in ccRCC
October 21st 2023Belzultifan in combination with cabozantinib generated durable responses independent of International Metastatic RCC Database Consortium risk category in patients with treatment-naïve clear cell renal cell carcinoma or those who had received prior immunotherapy.
Sacituzumab Govitecan Demonstrates Modest Activity in Pretreated HNSCC
October 21st 2023Sacituzumab govitecan-hziy led to modest but durable antitumor activity with predominant gastrointestinal toxicities in patients with metastatic or locally recurrent head and neck squamous cell carcinoma who received between 1 and 3 prior lines of therapy.
FDA Expands Entrectinib Indication in Pediatric Patients With NTRK+ Solid Tumors
October 20th 2023The FDA has granted accelerated approval to entrectinib (Rozlytrek) for pediatric patients aged older than 1 month with solid tumors that harbor a NTRK gene fusion without a known acquired resistance mutation, are metastatic, or where surgical resection is likely to result in severe morbidity, and have progressed after treatment or have no satisfactory standard therapy options.
Atezolizumab Plus Chemotherapy Fails to Provide Clinical Benefit in Recurrent Ovarian Cancer
October 20th 2023Patients with recurrent ovarian cancer did not experience a statistically significant improvement in clinical outcomes such as progression-free survival and objective response rate with the addition of atezolizumab to chemotherapy and niraparib maintenance therapy.
Neoadjuvant Pembrolizumab Plus Chemotherapy Boosts pCR in ER+/HER2– Breast Cancer
October 20th 2023Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab plus endocrine therapy generated a statistically significant increase in pathologic complete response vs neoadjuvant placebo plus chemotherapy followed by adjuvant pembrolizumab and endocrine therapy in patients with high-risk, early-stage, estrogen receptor–positive, HER2-negative breast cancer.
Dostarlimab Plus Chemo Continues to Demonstrate Strong Clinical Efficacy in Advanced NSCLC
October 20th 2023Dostarlimab plus chemotherapy elicited a higher objective response rate and showcased a numerical improvement in overall survival compared with pembrolizumab and chemotherapy in patients with treatment-naïve, nonsquamous non–small cell lung cancer.
Lutetium Lu 177 Vipivotide Tetraxetan Plus Enzalutamide Elicits PSA-PFS Improvement in mCRPC
October 20th 2023Treatment with the combination of lutetium Lu 177 vipivotide tetraxetan and enzalutamide led to an improvement in prostate-specific antigen progression-free survival vs enzalutamide alone in patients with metastatic castration-resistant prostate cancer.
Pembrolizumab Plus Neoadjuvant Chemotherapy Produces Long-Term Survival Benefits in High-Risk TNBC
October 20th 2023Treatment with neoadjuvant pembrolizumab in combination with platinum-containing chemotherapy and followed by adjuvant pembrolizumab improved event-free survival compared with neoadjuvant chemotherapy alone in patients with high-risk triple-negative breast cancer.
Frontline Pembrolizumab Plus Trastuzumab/Chemotherapy Improves PFS in HER2+ Gastric/GEJ Cancer
October 20th 2023The addition of pembrolizumab to combination of trastuzumab and chemotherapy led to an improvement in progression-free survival vs placebo plus trastuzumab and chemotherapy in the first-line treatment of patients with metastatic HER2-positive gastric or gastroesophageal junction cancer, particularly in those whose tumors had a PD-L1 combined positive score.
Pembrolizumab Plus Adagrasib Demonstrates Preliminary Efficacy in KRAS G12C–Mutated NSCLC
October 20th 2023Concurrent adagrasib and pembrolizumab generated early signals of efficacy in patients with treatment-naïve, advanced non–small cell lung cancer harboring KRAS G12C mutations, particularly in those who had a PD-L1 tumor proportion score of at least 50%.