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.
FDA Grants Priority Review to Relatlimab/Nivolumab for Unresectable or Metastatic Melanoma
September 20th 2021The FDA has granted priority review to a biologics license application for the fixed-dose combination of relatlimab plus nivolumab for the treatment of adult and pediatric patients aged 12 years and older and weighing at least 40 kg who have unresectable or metastatic melanoma.
Liso-cel Plus Ibrutinib Demonstrates Tolerable Safety Profile in Relapsed/Refractory CLL/SLL
September 19th 2021Lisocabtagene maraleucel in combination with ibrutinib was associated with manageable safety for patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, according to updated data from the phase 1 TRANSCEND-CLL-004 trial.
Adagrasib Shows Impressive Activity in KRAS G12C–Mutant CRC
September 19th 2021Adagrasib alone or in combination with cetuximab elicited encouraging antitumor activity and safety in heavily pretreated patients with KRAS G12C–mutant colorectal cancer, according to findings from the phase 1/2 KRYSTAL-1 trial.
Prednisone Added to ADT Plus Docetaxel Improves Radiographic PFS and OS in mCSPC
September 19th 2021Prednisone added to androgen-deprivation therapy plus docetaxel improved radiographic progression-free survival and overall survival in patients with de novo metastatic castration-sensitive prostate cancer.
Switch to Darolutamide Maintenance Improves Survival in Taxane and NHA Pretreated mCRPC
September 19th 2021Switching maintenance to darolutamide following taxane-based therapy with at least 1 novel hormonal agent showed statistically significant but clinically modest improvement in radiographic progression-free survival and event-free survival in patents with metastatic castration-resistant prostate cancer.
Datopotamab Deruxtecan May Lead to Antitumor Activity in Advanced NSCLC With Genomic Alterations
September 19th 2021The antibody drug conjugate datopotamab deruxtecan demonstrated safe antitumor activity in patients with advanced/metastatic non-small cell lung cancer with actionable genomic alterations.
Trastuzumab Duocarmazine Shows PFS Benefit in Pretreated, HER2+ Metastatic Breast Cancer
September 19th 2021Vic-trastuzumab duocarmazine yielded an improved progression-free survival over standard physician’s choice chemotherapy in patients with pretreated HER2-positive locally advanced or metastatic breast cancer.
Trastuzumab Deruxtecan Bests T-DM1 in First Head-to-Head Study for HER2+ Breast Cancer
September 18th 2021Fam-trastuzumab deruxtecan-nxki demonstrated a clinically meaningful and statistically significant improvement in progression-free survival vs standard of care trastuzumab emtansine for patients with previously treated HER2-positive metastatic breast cancer.
cfDNA-Based MRD Assessment Is Feasible, Yields Highly Concordant Results in Relapsed/Refractory CLL
September 18th 2021The use of a cell-free DNA–based minimal residual disease assay demonstrated feasibility and highly concordant results compared with 4-color flow cytometry and improved MRD detection in patients with chronic lymphocytic leukemia who were treated with time-limited venetoclax, acalabrutinib, and obinutuzumab.
Pembrolizumab/Chemo With or Without Bevacizumab May Represent New Frontline SOC in Cervical Cancer
September 18th 2021The addition of pembrolizumab to chemotherapy with or without bevacizumab significantly improved survival and response rates in patients with persistent, recurrent, or metastatic cervical cancer.
Pembrolizumab/Olaparib Combo May Improve PSA Response Regardless of HRR Mutation Status in mCRPC
September 18th 2021Pembrolizumab plus olaparib may improve prostate-specific antigen response rate in patients with metastatic castration-resistant prostate cancer regardless of homologous recombination repair mutation status.
Daily Poziotinib Shows Promise in Untreated HER2 Exon 20–Mutant NSCLC
September 18th 2021Poziotinib, administered once daily at 16 mg, induced a median tumor reduction of 35% in patients with treatment-naïve non–small cell lung cancer harboring HER2 exon 20 mutations, according to findings from cohort 4 of the ongoing phase 2 ZENITH20 trial.
Relatlimab/Nivolumab Improves TFI and PFS2 in Frontline Advanced Melanoma
September 18th 2021The addition of relatlimab to nivolumab prolonged benefit beyond initial treatment and first progression and reduced the risk of progression or death after the next line of systemic therapy vs nivolumab alone in previously untreated patients with metastatic or unresectable melanoma.
Osimertinib/Bevacizumab Combo Does Not Improve PFS in EGFR-Mutant NSCLC
September 18th 2021The combination of osimertinib and bevacizumab did not produce a superior progression-free survival benefit vs osimertinib alone in patients with non-squamous non-small cell lung cancer harboring an EGFR mutation.