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/Ipilimumab Combo Does Not Improve Survival, Shows Higher Toxicity in PD-L1+ NSCLC
January 30th 2021January 29, 2021 - Pembrolizumab plus ipilimumab did not improve survival and had higher rates of toxicity versus pembrolizumab monotherapy as a first-line treatment for patients with metastatic non–small cell lung cancer who had a PD-L1 tumor proportion score of 50% or greater, and did not harbor EGFR or ALK aberrations.
Mobocertinib Shows Encouraging ORR in EGFR Exon 20–Mutant Advanced NSCLC
January 30th 2021January 29, 2021 — Mobocertinib (formerly TAK-788) demonstrated clinically meaningful benefit and a manageable safety profile in previously treated patients with metastatic non–small cell lung cancer who have EGFR exon 20 insertion mutations.
Selinexor Approaches EU Approval for Refractory Multiple Myeloma
January 30th 2021January 29, 2021 - The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for selinexor for use in combination with dexamethasone in the treatment of select adult patients with refractory multiple myeloma.
Datopotamab Deruxtecan Elicits Early Antitumor Activity in Relapsed/Refractory Metastatic NSCLC
January 29th 2021January 29, 2021 - The investigational antibody-drug conjugate datopotamab deruxtecan demonstrated encouraging antitumor activity and a manageable safety profile in patients with advanced or metastatic non–small cell lung cancer.
Patritumab Deruxtecan Displays Promising Efficacy in EGFR-Mutant NSCLC
January 29th 2021January 29, 2021 - The HER3-directed antibody-drug conjugate patritumab deruxtecan continued to demonstrate clinically meaningful antitumor activity and a manageable safety profile at the recommended expansion dose of 5.6 mg/kg in pretreated patients with metastatic or unresectable EGFR-mutant non–small cell lung cancer.
Adjuvant Osimertinib Extends DFS Irrespective of Prior Adjuvant Chemo in EGFR+ NSCLC
January 29th 2021January 29, 2021 - Adjuvant osimertinib was found to improve disease-free survival in patients with EGFR-mutated non–small cell lung cancer, irrespective of previous adjuvant chemotherapy received or disease stage.
Trastuzumab Deruxtecan Shows Antitumor Activity in HER2-Overexpressing NSCLC
January 29th 2021January 29, 2021 - The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki demonstrated antitumor activity in patients with HER2-overexpressing non–small cell lung cancer, irrespective of expression levels.
Nab-Paclitaxel Noninferior to Docetaxel in Previously Treated NSCLC
January 29th 2021January 29, 2021 - Nab-paclitaxel proved to be noninferior to docetaxel, having showcased improved progression-free survival, overall survival, and overall response rate in patients with previously treated advanced non–small cell lung cancer.
Bemcentinib Plus Pembrolizumab Shows Clinical Activity in Advanced NSCLC
January 29th 2021January 29, 2021 - The first-in-class oral kinase inhibitor bemcentinib, when used in combination with pembrolizumab, demonstrated clinical activity with favorable tolerability in patients with checkpoint inhibitor–naïve and CPI-refractory composite AXL–positive non–small cell lung cancer.
Redefining BCLC B, Intermediate-Stage HCC: Is There a Role for Combination Systemic Therapy?
January 29th 2021BCLC B intermediate stage hepatocellular carcinoma, defined as patients with unresectable, liver-limited disease and preserved liver function, encompasses a broad range of patients with variable tumor size, number, and location.
Sotorasib Elicits Rapid Responses, Encouraging PFS in Advanced KRAS G12C+ NSCLC
January 29th 2021January 28, 2021 - Treatment with the KRAS G12C inhibitor sotorasib (formerly AMG 510) elicited a 6.8-month median progression-free survival in patients with KRAS G12C–mutated advanced non–small cell lung cancer.
NeoADAURA Trial Slated to Examine Neoadjuvant Osimertinib in Resectable EGFR+ NSCLC
January 28th 2021January 28, 2021 - The NeoADAURA trial will evaluate the safety and efficacy of neoadjuvant osimertinib, as a single agent or in combination with platinum-based chemotherapy compared with chemotherapy alone, in patients with resectable, stage II-IIIB non–small cell lung cancer whose tumors harbor EGFR mutations.
Osimertinib/Savolitinib Combo May Overcome MET Resistance in EGFR+, MET-Amplified NSCLC
January 28th 2021January 28, 2021 - The combination of osimertinib and savolitinib may be able to overcome MET resistance in patients with EGFR-mutant, MET-amplified or -overexpressed non–small cell lung cancer, including those who have previously progressed on a prior EGFR TKI.
Updated OS Analysis Favors Frontline Atezolizumab in PD-L1–High NSCLC
January 28th 2021January 28, 2021 - Atezolizumab demonstrated continued clinically meaningful benefits in overall survival, progression-free survival, overall response rate, and duration of response compared with chemotherapy in patients with PD-L1–high wild-type nonsquamous or squamous non–small cell lung cancer.
BMS-986012 Plus Nivolumab May Be Effective in Treating Relapsed/Refractory SCLC
January 28th 2021January 28, 2021 - Adding BMS-986012, anti–fucosyl-GM1 monoclonal antibody, to nivolumab demonstrated promising results in the treatment of patients with relapsed/refractory small cell lung cancer who did not receive previous checkpoint inhibitor therapy.
Osimertinib Displays Uniform Brain Penetrance and Reduced Metastatic Volume in EGFR+ NSCLC
January 28th 2021January 28, 2021 - Rapid, high, and uniform brain exposure was seen with [11C]osimertinib, followed by a reduction in total brain metastases volume with oral administration of the EGFR TKI in patients with EGFR-mutant non–small cell lung cancer and brain metastases.
Real-World Study Confirms NRG1 Fusions in NSCLC, Supports Afatinib Studies
January 28th 2021January 28, 2021 - NRG1 fusions are detectable in patients with non–small cell lung cancer, providing a rationale to perform larger, retrospective studies assessing therapeutic outcomes in patients with NRG1 fusion–positive tumors and evaluate afatinib in this patient subgroup.
Frontline Pembrolizumab Maintains Survival Benefit Over Chemo in PD-L1+ NSCLC
January 28th 2021January 28, 2021 — Frontline pembrolizumab continued to demonstrate clinically meaningful improvements in overall survival, overall response rate, and time to progression on next-line therapy compared with platinum-based chemotherapy in patients with locally advanced or metastatic PD-L1–positive non–small cell lung cancer without sensitizing EGFR or ALK mutations.
NCCN and ACS Call for Resumption of Cancer Screening, Treatment Amidst COVID-19 Crisis
January 28th 2021January 28, 2021 - The National Comprehensive Cancer Network and the American Cancer Society are collaborating with cancer organizations nationwide to promote the resumption of cancer screening and treatment during the coronavirus disease 2019 pandemic.
Pembrolizumab Continues to Improve Survival in PD-L1–Positive Advanced NSCLC
January 28th 2021January 28, 2021 - Pembrolizumab continued to demonstrate a clinically meaningful improvement in overall and progression-free survival, compared with docetaxel, in patients with previously treated, PD-L1–positive advanced non-small cell lung cancer after more than 5 years of follow-up.
Pembrolizumab/Chemo Demonstrates Continued OS Improvement in Nonsquamous NSCLC
January 28th 2021January 28, 2021 — Pembrolizumab in combination with chemotherapy continued to show improved overall survival and progression-free survival compared with chemotherapy alone in patients with previously untreated metastatic nonsquamous non–small cell lung cancer.
Tislelizumab Prolongs Survival in Advanced, Unresectable, or Metastatic ESCC
January 28th 2021January 28, 2021 - The anti–PD-1 antibody tislelizumab was found to significantly improve overall survival compared with investigator’s choice of chemotherapy in the treatment of patients with advanced, unresectable, or metastatic esophageal squamous cell carcinoma.