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.
CD47 Blocker ALX148 Safe to Combine With Antibody Regimens, Chemotherapy in Gastric/GEJ and HNSCC
November 13th 2020November 13, 2020 - ALX148 showcased favorable safety and elicited objective responses when combined with trastuzumab, pembrolizumab, and multiagent chemotherapy regimens in patients with gastric/gastroesophageal junction cancer and head and neck squamous cell carcinoma.
Herpes Simplex-1 Oncolytic Showcases Antitumor Activity Across Heavily Pretreated Solid Tumors
November 13th 2020November 13, 2020 - The genetically modified herpes simplex-1 oncolytic RP2 demonstrated encouraging clinical activity and an acceptable safety profile in heavily pretreated patients with advanced solid tumors
FDA Approves Pembrolizumab/Chemo for Locally Recurrent Unresectable or Metastatic TNBC
November 13th 2020November 13, 2020 - The FDA has granted an accelerated approval to pembrolizumab for use in combination with chemotherapy in the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1 as determined by an FDA-approved test.
Nivolumab/Ipilimumab Combo Is Effective, Safe in Advanced or Unresectable Angiosarcoma
November 13th 2020November 13, 2020 - The combination of nivolumab and ipilimumab elicited an objective response rate of 25% and was found to be well tolerated in patients with advanced or unresectable angiosarcoma, according to cohort findings of the phase 2 DART trial.
CMP-001 Plus Pembrolizumab Elicits Deep Responses, Reverses PD-1 Resistance in Advanced Melanoma
November 12th 2020November 12, 2020 - The combination of CMP-001 intratumoral injection and pembrolizumab was found to reverse PD-1 blockade resistance and elicit durable systemic responses in patients with advanced melanoma.
Next-Generation Bispecific Antibody Shows Early Clinical Activity in Advanced Solid Tumors
November 12th 2020November 12, 2020 - The first-in-class, next-generation, DuoBody-PD-L1×4-1BB bispecific antibody GEN1046 demonstrated promising early activity and an acceptable safety profile in in patients with advanced solid tumors.
Cabozantinib/Pembrolizumab Trial Poised to Improve Efficacy, Safety in Advanced Melanoma
November 12th 2020November 12, 2020 - In an effort to further improve outcomes without sacrificing tolerability, the combination of cabozantinib with pembrolizumab is being evaluated in patients with advanced melanoma in a phase 1b/2 study.
Antibody-Drug Conjugates Carve Out Space in Urothelial Carcinoma Landscape
November 12th 2020Monoclonal antibodies have played a key role in the development of personalized oncology and have proven antitumor activity through multiple mechanisms, including direct transmembrane signaling leading to apoptosis, complement mediated cytotoxicity, antibody-dependent cellular cytotoxicity, and inhibiting tumor vasculature and stroma.
Initial Data from NCI-MATCH Spotlight the Growing Need for Precision Medicine in Oncology
November 11th 2020Keith T. Flaherty, MD, discusses the rationale to conduct the NCI-MATCH trial, key findings from the recent publication, and potential permutations of the trial design that could further the role of precision medicine in oncology.
Bemarituzumab Plus Chemotherapy Significantly Improves Survival in FGFRb+ Gastric/GEJ Cancer
November 11th 2020The addition of the first-in-class targeted therapy bemarituzumab to chemotherapy significantly improved progression-free survival and overall survival versus chemotherapy alone in the frontline treatment of patients with FGFRb-positive, locally advanced or metastatic gastric and gastroesophageal junction cancer.
Adagrasib Shows Early Efficacy in KRAS G12C-Mutant NSCLC and CRC
November 11th 2020Adagrasib, a novel agent aimed at KRAS G12C mutations, has demonstrated early signs of efficacy in patients with advanced non–small cell lung cancer and colorectal cancer whose tumors harbor the alteration, raising hopes for a new therapy against a challenging oncogenic target.
Enzalutamide Approved in China for Nonmetastatic Castration-Resistant Prostate Cancer
November 11th 2020November 10, 2020 - The China National Medical Products Administration has approved enzalutamide for the treatment of adult patients with nonmetastatic castration-resistant prostate cancer who are at a higher risk of metastasis.
Active Surveillance Found Feasible Among African Americans With Low-Risk Prostate Cancer
November 9th 2020African American men with low-risk prostate cancer who received active surveillance had a statistically significant increased 10-year cumulative incidence of disease progression and definitive treatment compared with non-Hispanic white men.
Atezolizumab/Bevacizumab Approved in Europe for Advanced or Unresectable HCC
November 2nd 2020The European Commission has approved the combination of atezolizumab plus bevacizumab for use in adult patients with advanced or unresectable hepatocellular carcinoma who have not been given previous systemic therapy.
Chemoimmunotherapy Combos “Game-Changing” in Frontline Metastatic NSCLC
October 30th 2020Nicholas Rohs, MD, discusses the progress made with chemoimmunotherapy combinations in frontline non–small cell lung cancer, future research directions, and emerging approaches that seek to propel progress in this disease.
Treatment Based on Advanced Molecular Imaging Can Improve DFS in Prostate Cancer
October 28th 2020The use of advanced molecular imaging with the PET radiotracer fluciclovine (18F) to inform treatment decisions can lead to improved disease-free survival rates in patients with recurrent prostate cancer.
Approval Sought for Cabozantinib/Nivolumab for Unresectable, Advanced, or Metastatic RCC in Japan
October 27th 2020A supplemental application was submitted to the Japanese Ministry of Health, Labour, and Welfare for Manufacturing and Marketing approval of the combination of cabozantinib plus nivolumab for the treatment of patients with unresectable, advanced, or metastatic renal cell carcinoma.
FDA Grants Priority Review to Adjuvant Osimertinib for Early-Stage EGFR+ Lung Cancer
October 20th 2020The FDA has granted osimertinib a priority review designation to a supplemental new drug application for the adjuvant treatment of patients with early-stage EGFR-mutated non–small cell lung cancer following complete tumor resection with curative intent.
KTE-X19 Granted Positive EU Opinion for Relapsed/Refractory MCL
October 16th 2020The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for KTE-X19 as a treatment in adult patients with relapsed/refractory mantle cell lymphoma who previously received 2 or more lines of systemic therapy, including a BTK inhibitor.