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.
Durvalumab Plus Chemotherapy Improves pCR in Resectable NSCLC
June 30th 2022Neoadjuvant treatment with durvalumab plus platinum-based chemotherapy led to a statistically significant improvement in pathologic complete response and major pathologic response compared with chemotherapy alone in patients with resectable non–small cell lung cancer, according to findings from a planned interim analysis of the phase 3 AEGEAN trial.
Durvalumab Plus Chemotherapy Maintains OS Benefit in Advanced Biliary Tract Cancer
June 30th 2022The addition of durvalumab to gemcitabine and cisplatin demonstrated an improvement in overall survival vs gemcitabine and cisplatin plus placebo as frontline therapy in patients with advanced biliary tract cancer, regardless of primary tumor location.
Botensilimab/Balstilimab Combo Produces Deep Responses in Microsatellite Stable CRC
June 29th 2022The combination of botensilimab and balstilimab elicited deep objective responses with evidence of durability and encouraging tolerability in heavily pretreated patients with microsatellite stable, metastatic colorectal cancer.
Atezolizumab Does Not Improve pCR in HER2-Positive Early Breast Cancer
June 29th 2022Adding atezolizumab to neoadjuvant standard of care therapy for HER2-positive early breast cancer did not result in a better pathologic complete response compared with placebo, according to findings from the phase 3 IMpassion050 trial.
Second-Line RGX-202-01 Plus FOLFIRI/Bevacizumab Shows Early Efficacy, Safety in KRAS-Mutant CRC
June 29th 2022A second-line combination regimen comprised of RGX-202-01, FOLFIRI and bevacizumab demonstrated an encouraging efficacy signal and a favorable toxicity profile in patients with KRAS-mutant colorectal cancer.
FDA Grants Breakthrough Therapy Designation to Talquetamab for Relapsed/Refractory Myeloma
June 29th 2022The FDA has granted a breakthrough therapy designation to talquetamab for use as a potential therapeutic option in patients with relapsed or refractory multiple myeloma who received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.
Socazolimab Shows Early Efficacy, Safety in Recurrent or Metastatic Cervical Cancer
June 29th 2022Socazolimab produced encouraging response rates with an acceptable safety profile in patients with recurrent or metastatic cervical cancer, irrespective of PD-L1 status, according to findings from the dose-expansion portion of a phase 1 trial.
Liso-cel Approval Provides Earlier, Expanded Access to CAR T-cell Therapy in Second-line LBCL
June 29th 2022Second-line lisocabtagene maraleucel provides an earlier CAR T-cell treatment option that improves survival outcomes and produces a manageable safety profile in patients with relapsed/refractory large B-cell lymphoma, including those who are older and have comorbidities.
Investigators Explore RARA Overexpression With Tamibarotene in Higher-Risk MDS
June 28th 2022Risk stratification for patients with myelodysplastic syndrome have afforded those with asymptomatic or low-risk disease treatment pathways that can be navigated using a variety of patient characteristics. However, treatment algorithms for patients with higher-risk disease are limited to allogeneic transplant or treatment with hypomethylating agents.
HER-Vaxx Plus Chemotherapy Improves OS in HER2+ Advanced Gastric/GEJ Cancer
June 28th 2022The addition of the HER2-Vaxx vaccine to standard-of-care chemotherapy led to a significant improvement in overall survival vs SOC chemotherapy alone in patients with HER2-neu overexpressing advanced and metastatic gastric and gastroesophageal junction cancer.
Obe-cel CAR T-cell Therapy Demonstrates Promising Safety Profile in Relapsed/Refractory B- ALL
June 28th 2022Daniel DeAngelo MD, PhD, discusses the data seen with obecabtagene autoleucel as a novel treatment in the CAR T-cell arena, emphasizes unmet needs in B-cell acute lymphoblastic leukemia, and highlights important next steps in the study of obe-cel.
FDA Places Partial Clinical Hold on Phase 1 Study of NUV-422 in Solid Tumors
June 27th 2022The FDA has placed a partial clinical hold on the phase 1/2 NUV-422-02 trial evaluating the selective small molecule CDK2/4/6 inhibitor NUV-422 in patients with solid tumors such as high-grade glioma, hormone receptor–positive advanced breast cancer, and metastatic castration-resistant prostate cancer.
Olaparib Approaches EU Approval for BRCA+, High-Risk Early Breast Cancer
June 27th 2022The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of olaparib for the adjuvant treatment of patients with germline BRCA-mutated, HER2-negative, high-risk, early breast cancer who have received neoadjuvant or adjuvant chemotherapy.
CHMP Supports Approval for Trastuzumab Deruxtecan in Metastatic HER2-Positive Breast Cancer
June 27th 2022The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the approval of trastuzumab deruxtecan monotherapy for patients with metastatic HER2-positive breast cancer who have received at least 1 prior anti–HER2-based regimen.
Japanese Regulatory Approval Sought for Trastuzumab Deruxtecan in HER2-Low Metastatic Breast Cancer
June 27th 2022A supplemental New Drug Application has been submitted to Japan’s Ministry of Health, Labour, and Welfare seeking approval for use of trastuzumab deruxtecan for the treatment of adult patients with HER2-low unresectable or recurrent metastatic breast cancer following chemotherapy
Sylvester Researchers Uncover New Cellular Oxygen-Sensing Pathway
June 27th 2022A team of researchers with Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine has identified a new cellular oxygen-sensing pathway – a discovery that could potentially lead to new approaches for treating cancer and other diseases.
Niraparib Plus Dostarlimab Misses the Mark in Platinum-Resistant Ovarian Cancer
June 25th 2022The combination of niraparib and dostarlimab produced a low overall response rate in patients with platinum-resistant ovarian cancer without a known BRCA mutation who had progressed and received prior bevacizumab, one that did not reach the threshold for second-stage accrual to the phase 2 MOONSTONE/GOG-3032 trial.
FDA Approves Liso-cel for Second-Line Relapsed/Refractory LBCL
June 24th 2022The FDA has approved lisocabtagene maraleucel as second-line therapy for adult patients with large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.