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.
Week 24 Transfusion Independence With Momelotinib Is Associated With Improved OS in Myelofibrosis
June 10th 2021Week 24 transfusion independence was associated with an improvement in overall survival vs week 24 transfusion dependence in patients with myelofibrosis who were randomized to momelotinib in the phase 3 SIMPLIFY 1 and SIMPLIFY 2 trials.
Second-Line Liso-cel Demonstrates Significant Benefit Over SOC in Relapsed/Refractory LBCL
June 10th 2021Lisocabtagene maraleucel demonstrated a highly significant improvement in event-free survival, complete response rate, and progression-free survival over standard of care in the second-line treatment of patients with relapsed/refractory large B-cell lymphoma, meeting primary and secondary end points of the phase 3 TRANSFORM trial.
FDA Approves Lymphoseek for Pediatric Melanoma, Rhabdomyosarcoma, and Other Solid Tumors
June 10th 2021The FDA approved the radiopharmaceutical agent technetium Tc 99m tilmanocept injection (Lymphoseek) for accurate and precise lymph node identification in pediatric patients with melanoma, rhabdomyosarcoma, and other types of solid tumors.
CTC Evaluation Fails to Demonstrate Functional Significance in HER2-Negative Breast Cancer
June 10th 2021Although circulating tumor cell analysis of patients with HER2-negative metastatic breast cancer identified patients with CTC amplification, the utility of subsequent HER2-directed treatment with trastuzumab plus vinorelbine in this patient population was low.
The US Oncology Network Highlights Success With Oncology Care Model
June 10th 2021Practices participating in the Oncology Care Model, an experimental payment model developed by the Center for Medicare and Medicaid Innovation, are incentivized to improve patient experiences and outcomes by providing enhanced services and care while bending the total cost curve.
Novel Combination Holds Potential to Address All Hallmarks of Myelofibrosis
June 10th 2021In an effort to build on the efficacy demonstrated with ruxolitinib, investigators are evaluating combination therapies—specifically the dual inhibition of the JAK-STAT and BET pathways using pelabresib, a novel BET inhibitor.
Regorafenib/Pembrolizumab Combination Yields Encouraging Results in Advanced HCC
June 10th 2021The combination of regorafenib plus pembrolizumab in the first-line setting for patients with advanced hepatocellular carcinoma showed encouraging anti-tumor activity with a disease control rate of 91%, and did not display any new safety signals.
Frontline Belzutifan Showcases Significant Clinical Activity in VHL-Associated RCC
June 9th 2021The hypoxia-inducible factor-2 alpha inhibitor belzutifan maintained clinical efficacy with further follow-up in patients with Von-Hippel Lindau–associated renal cell carcinoma, as well as other VHL-associated neoplasms.
Lenvatinib/Pembrolizumab Yields Survival Benefit in Advanced RCC Across IMDC Risk Groups
June 9th 2021The addition of lenvatinib to pembrolizumab elicited a notable survival benefit and improved responses over single-agent sunitinib in patients with advanced renal cell carcinoma across evaluable International Metastatic RCC Database Consortium risk subgroups.
Duvelisib Approved in Europe for Relapsed/Refractory CLL or Follicular Lymphoma
June 9th 2021The European Medicines Agency has granted marketing authorization to duvelisib for single-agent use in patients with relapsed/refractory chronic lymphocytic leukemia who have previously received at least 2 therapies or those with follicular lymphoma whose disease is refractory to at least 2 previous systemic therapies.
Pembrolizumab/Cabozantinib Combo Provides Benefit in mRCC
June 9th 2021The combination of pembrolizumab and cabozantinib induced a response in more than half of patients with metastatic renal cell carcinoma at the recommended phase 2 dose with a manageable safety profile, meeting the primary end point of a phase 1/2 trial.
FDA Extends Review Period for Ruxolitinib in Chronic GVHD
June 9th 2021The FDA has extended the review period for the supplemental new drug application for ruxolitinib as a therapeutic option for adult and pediatric patients aged 12 years and older with steroid-refractory chronic graft-versus-host disease.
Addition of Abiraterone to ADT plus Docetaxel Yields Improvement in rPFS in De Novo mCSPC
June 9th 2021Adding abiraterone acetate and prednisone to androgen-deprivation therapy plus docetaxel improved radiographic progression-free survival in patients with de novo metastatic castration-sensitive prostate cancer.
Subcutaneous Elranatamab Elicits Encouraging Responses in Relapsed/Refractory Myeloma
June 8th 2021The BCMA-targeting humanized bispecific monoclonal antibody elranatamab elicited high response rates when subcutaneously delivered at higher doses in patients with relapsed/refractory multiple myeloma.
Subsequent Therapy May Impact OS Outcomes With Frontline Lenvatinib/Everolimus in RCC
June 8th 2021Subsequent systemic therapies were found to impact overall survival outcomes with lenvatinib plus everolimus versus sunitinib in patients with advanced renal cell carcinoma who received treatment in the phase 3 CLEAR trial.
Talquetamab at RP2D Elicits High Clinical Response Rate in Relapsed/Refractory Multiple Myeloma
June 8th 2021Talquetamab, when delivered at the recommended phase 2 dose of 405 µg/kg weekly, induced a high clinical response rate with favorable tolerabilty in patients with relapsed/refractory multiple myeloma.
TAK-700 Plus ADT Significantly Improves PFS and PSA Responses in mHSPC, But Not OS
June 8th 2021The addition of TAK-700 to androgen-deprivation therapy improved median progression-free survival and prostate-specific antigen responses, but did not significantly improve overall survival vs ADT and bicalutamide in patients with newly diagnosed metastatic hormone-sensitive prostate cancer.
Pimitespib Doubles PFS in Advanced Refractory GIST
June 8th 2021The heat shock protein 90 inhibitor pimitespib led to a significant improvement in progression-free survival and prolongation in overall survival compared with placebo in patients with advanced gastrointestinal stromal tumor that is refractory to imatinib, sunitinib, and regorafenib.
Alrizomadlin/Pembrolizumab Induces Early Efficacy in Unresectable Melanoma or Advanced Solid Tumors
June 8th 2021The addition of alrizomadlin to pembrolizumab yielded promising preliminary efficacy and was tolerable in patients with unresectable or metastatic melanoma or advanced solid tumors that have been resistant to immunotherapy agents.
Trastuzumab Duocarmazine Shows Superiority Over Physician’s Choice for HER2+ Breast Cancer
June 8th 2021The antibody-drug conjugate vic-trastuzumab duocarmazine was found to significantly improve progression-free survival over physician’s choice of treatment in patients with pretreated HER2-positive unresectable locally advanced or metastatic breast cancer, meeting the primary end point of the phase 3 TULIP trial.