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.
Amivantamab Provides Long-term Clinical Benefit in Post-Platinum EGFR Exon 20 Insertion+ NSCLC
March 30th 2023Amivantamab continued to be tolerable and efficacious in patients with non–small cell lung cancer harboring EGFR exon 20 insertion mutations whose disease progressed on platinum-based chemotherapy.
FDA Grants Full Approval to Pembrolizumab for Select Patients With MSI-H or dMMR Solid Tumors
March 29th 2023The FDA has granted full approval to pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability–high or mismatch repair–deficient solid tumors that have progressed following previous treatment and who have no satisfactory alternative options.
TALAPRO-2 Data Underscore Potential of Talazoparib Plus Enzalutamide in mCRPC
March 29th 2023Neeraj Agarwal, MD, discusses preclinical data that supported the launch of the TALAPRO-2 trial and key efficacy and safety data on the use of talazoparib plus enzalutamide in patients with metastatic castration-resistant prostate cancer irrespective of homologous recombination repair mutational status.
European Commission Approves Cemiplimab Plus Chemotherapy for First-line PD-L1+ NSCLC
March 29th 2023The European Commission has approved cemiplimab-rwlc plus platinum-based chemotherapy for the frontline treatment of patients with locally advanced or metastatic PD-L1–positive non–small cell lung cancer without EGFR, ALK, or ROS1 alterations and who are not eligible for chemoradiation.
Neoadjuvant Olaparib Proves Feasible, Aids Optimal Resection in BRCA-Mutant Ovarian Cancer
March 28th 2023Neoadjuvant treatment with olaparib prior to surgical resection and adjuvant chemotherapy was well tolerated and led to a 100% optimal resection rate in patients with newly diagnosed, BRCA-mutant ovarian, primary peritoneal, or fallopian tube cancer.
Dostarlimab Plus Chemotherapy Elicits PFS Benefit in Recurrent Endometrial Cancer
March 28th 2023Dostarlimab plus standard-of-care chemotherapy generated a significant improvement in progression-free survival vs chemotherapy alone for patients with recurrent endometrial cancer, including those with mismatch repair–deficient, microsatellite instability–high tumors.
Pembrolizumab Plus Chemotherapy Improves Survival in dMMR/pMMR Advanced Endometrial Cancer
March 28th 2023Pembrolizumab plus standard-of-care chemotherapy, followed by maintenance pembrolizumab, reduced the risk of disease progression or death vs chemotherapy alone in patients with mismatch repair–deficient and mismatch repair–proficient advanced or recurrent endometrial cancer.
Fixed-Duration Ibrutinib Plus Venetoclax Earns Approval in Canada for Previously Untreated CLL
March 28th 2023Canada Health has approved the fixed-duration, all-oral combination of ibrutinib and venetoclax for the frontline treatment of adult patients with chronic lymphocytic leukemia, including those with 17p deletion.
Obe-cel May Prove a Tolerable Treatment Alternative in Relapsed/Refractory B-ALL
March 28th 2023Sameem Abedin, MD, discusses where CAR T-cell therapy falls in the treatment paradigm for B-cell acute lymphoblastic leukemia, the known safety profile of obe-cel as evidenced in early studies, and how findings from the FELIX trial could change the future management of this disease.
Lenvatinib Plus Pembrolizumab Produces Deep, Sustained Responses in Advanced Endometrial Cancer
March 27th 2023The combination of lenvatinib plus pembrolizumab produced deep, durable tumor responses in both all-comer and mismatch repair–proficient (pMRR) populations of patients with advanced endometrial cancer, according to data from the phase 3 Study 309/KEYNOTE-775 trial.
Ribociclib Plus Endocrine Therapy Meets iDFS End Point in HR+ Early Breast Cancer
March 27th 2023The combination of ribociclib and endocrine therapy (ET) significantly reduced the risk of disease recurrence vs standard adjuvant ET in patients with hormone receptor–positive/HER2-negative early breast cancer at risk of recurrence.
Trastuzumab Deruxtecan Garners Approval in Japan for HER2-Low Metastatic Breast Cancer
March 27th 2023Japan’s Ministry of Health, Labor and Welfare has approved fam-trastuzumab deruxtecan-nxki for the treatment of adult patients with HER2-low unresectable or recurrent breast cancer after prior chemotherapy.
Niraparib Maintenance Does Not Produce Long-term OS Benefit in Recurrent Ovarian Cancer
March 27th 2023Maintenance niraparib did not produce a statistically significant overall survival benefit compared with placebo in patients with recurrent ovarian cancer, according to data from an updated exploratory OS analysis of the phase 3 ENGOT-OV16/NOVA study.
Tolerability Hinders Adavosertib Activity in Recurrent or Persistent Uterine Serous Carcinoma
March 27th 2023Treatment with the oral, small-molecule Wee1 kinase inhibitor adavosertib was clinically active but not well tolerated in patients with recurrent or persistent uterine serous carcinoma who previously received platinum-based chemotherapy.
FDA Approval Sought for Lifileucel in Unresectable or Metastatic Melanoma
March 27th 2023Iovance Biotherapeutics has submitted a rolling biologics license application to the FDA seeking the approval of the tumor infiltrating lymphocyte therapy lifileucel for the treatment of patients with advanced unresectable or metastatic melanoma who progressed on or after prior anti–PD-1/L1 therapy and targeted therapy.
Olaparib Plus Selumetinib Produces Clinical Benefit in RAS-Mutated Ovarian and Endometrial Cancer
March 27th 2023The recommended phase 2 dose of olaparib plus selumetinib generated a clinical benefit in patients with endometrial or ovarian cancer harboring RAS mutations, according to findings from the dose-expansion portion of the phase 1b SOLAR trial.
Neoadjuvant Durvalumab/Tremelimumab Plus Chemo Meets PFS End Point in Advanced Ovarian Cancer
March 27th 2023Neoadjuvant treatment with the combination of durvalumab plus tremelimumab and chemotherapy elicited a promising 12-month progression-free survival rate in patients with advanced-stage ovarian cancer.