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.
Pembrolizumab/Pepinemab Combo Safe, Well Tolerated in Advanced, Recurrent, or Metastatic HNSCC
January 7th 2022The combination of pembrolizumab and pepinemab showcased encouraging safety and tolerability when given as first-line treatment in patients with advanced, recurrent, or metastatic head and neck squamous cell carcinoma.
Navigating the Nuances of Molecular Testing in NSCLC
January 7th 2022Charu Aggarwal, MD, MPH, shares how to navigate the nuances of molecular testing in non–small cell lung cancer, key developments made in the treatment of those whose tumors harbor actionable mutations, and the role of PD-L1 expression in informing clinical decisions.
CLN-081 Continues to Elicit Encouraging, Durable Responses in EGFR Exon 20 Insertion+ NSCLC
January 6th 2022CLN-081 continued to produce encouraging, durable responses with favorable safety and tolerability in patients with non–small cell lung cancer whose tumors harbor EGFR exon 20 insertion mutations and who have progressed on or after prior therapy.
FDA Accepts IND for RM-1995 Photoimmunotherapy in Advanced Cutaneous or Head and Neck SCC
January 6th 2022The FDA has accepted an investigational new drug application for the photoimmunotherapy treatment, RM-1995, for patients with advanced cutaneous squamous cell carcinoma or head and neck squamous cell carcinoma.
Aggarwal Shines a Light on Precision Medicine in Lung, Breast, Ovarian, and GI Cancers
January 6th 2022Molecular testing is an established and essential precursor to treatment for patients with non–small cell lung cancer based on the volume of actionable targets, such as EGFR and KRAS G12C mutations, as well as PD-L1 status.
Hepatectomy Plus Adjuvant mFOLFOX6 Improves DFS in Liver-Only Metastatic CRC
January 6th 2022Adjuvant chemotherapy with modified fluoropyrimidine, leucovorin, and oxaliplatin improved disease-free survival among patients with liver-only metastases from colorectal cancer who were treated with hepatectomy.
Roswell Park Receives Nearly $1 Million to Address Race-Related Disparities in Prostate Cancer
January 6th 2022New grants from the U.S. Department of Defense and American Cancer Society will fund work by two Roswell Park Comprehensive Cancer Center teams focused on understanding and eliminating prostate cancer health disparities.
Tucatinib Triplet Maintains OS Benefit in HER2+ Breast Cancer With Brain Metastases
January 6th 2022The combination of tucatinib, trastuzumab, and capecitabine continued to produce an improvement in overall survival compared with trastuzumab/capecitabine alone in patients with HER2-positive metastatic breast cancer who had stable or active brain metastases.
Mirati and Verastem Combine to Address Unmet Need in KRAS G12C–Mutant NSCLC
January 5th 2022Mirati Therapeutics and Verastem Oncology have entered a nonexclusive clinical collaboration to evaluate the combination of adagrasib plus VS-6766 for patients with non–small cell lung cancer harboring a KRAS G12C mutation who have progressed on a KRAS G12C inhibitor in a phase 1/2 trial.
Telisotuzumab Vedotin Receives Breakthrough Therapy Status From FDA for Select NSCLC
January 5th 2022The FDA granted a breakthrough therapy designation to telisotuzumab vedotin for use in patients with advanced or metastatic EGFR wild-type, nonsquamous non–small cell lung cancer who have high levels of c-Met overexpression and whose disease has progressed on, or after, platinum-based chemotherapy.
Bispecific Antibodies Hold Promise in HER2+ Breast Cancer
January 5th 2022Sara M. Tolaney, MD, MPH, discusses the mechanism of action that makes bispecific antibodies an intriguing approach in managing HER2-positive breast cancer, efficacy data with zanidatamab that were presented during the 2021 SABCS, and her thoughts on sequencing strategies with bispecific antibodies among other agents in the paradigm.
Tiragolumab Plus Atezolizumab Demonstrates Improvement in PFS, OS, ORR in PD-L1+ NSCLC
January 4th 2022The addition of tiragolumab to atezolizumab produced a clinically meaningful improvement in progression-free survival, overall survival, and objective response rate compared with atezolizumab alone in the first-line treatment of patients with PD-L1–positive non–small cell lung cancer.
CLN-081 Granted FDA Breakthrough Therapy Designation Status for EGFR-Mutated NSCLC
January 4th 2022The FDA has granted breakthrough therapy designation to CLN-081 for the treatment of patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations and who have received prior platinum-based chemotherapy.
Chemotherapy-Free Regimens Seek to Replace Current Standards in Metastatic HR+ Breast Cancer
January 4th 2022Sara Tolaney, MD, MPH, discusses the data with the oral selective estrogen receptor degrader, elacestrant, and the androgen receptor agonist, enobosarm, in estrogen receptor–positive, HER2-negative breast cancer.
The Future of Cancer Care Depends on Trust in the Scientific Community
January 4th 2022Maurie Markman, MD, shares how evidence strongly supports that approaches to cancer prevention have little chance of success unless those being targeted are willing to listen to, and ultimately trust, the recommendations being made by members of the scientific community.
FDA Grants Fast Track Status to Novel Gene Therapy Plus Pembrolizumab for Late-Stage NSCLC
January 3rd 2022The FDA has granted a fast track designation to a combination comprised of the immunogene therapy quaratusugene ozeplasmia and pembrolizumab for use in select patients with late-stage non–small cell lung cancer.
Japanese Approval Sought for Valemetostat in Relapsed/Refractory Adult T-Cell Leukemia/Lymphoma
January 3rd 2022A new drug application seeking the approval of valemetostat tosylate for use in the treatment of patients with relapsed/refractory adult T-cell leukemia/lymphoma has been submitted to the Japanese Ministry of Health, Labour, and Welfare.