HRQOL Analysis From CLEAR Trial Further Support Pembrolizumab/Lenvatinib Combo for Frontline RCC
June 7th 2021Across 3 health-related quality of life scales, the combination of pembrolizumab plus lenvatinib had similar or better outcomes than sunitinib for patients with metastatic renal cell carcinoma receiving treatment in the frontline.
VERSATILE-002 Trial to Enroll Previously Treated HPV+ HNSCC Per Protocol Amendment
June 3rd 2021A new treatment arm of a phase 2 trial examining PDS0101 plus pembrolizumab in patients with HPV-related head and neck cancers will be opened to patients with immune checkpoint inhibitor–pretreated disease.
Bispecific CD3/CD123-Targeted Antibody APVO436 Shows Promise in AML/MDS
May 31st 2021Investigators successfully established the phase 2 dose of APVO436 for patients with acute myeloid leukemia or myelodysplastic syndrome after an acceptable safety profile was achieved in patients with responses to therapy.
Real-World Data Support the Use of Later-Line Eribulin in Metastatic Breast Cancer
May 26th 2021Investigators aimed to determine if oncologic outcomes of patients in the real-world setting matched those of a pivotal clinical trial that led to the approval of eribulin mesylate in patients with metastatic breast cancer.
Ublituximab Plus Umbralisib Considered for Treatment of CLL/SLL by FDA
May 26th 2021Based on phase 3 data supporting the use of ublituximab in combination with umbralisib versus an existing standard-of-care regimen for chronic lymphocytic leukemia and small cell lymphoma, the FDA has moved forward with a review of the application for approval.
Rituximab Added to 177-Lu Lilotomab Satetraxetan Induces High Response Rate in R/R FL
May 26th 2021The radioimmunotherapy 177-Lu lilotomab satetraxetan in combination with rituximab led to a 100% response rate in a small cohort of patients with follicular lymphoma who were receiving treatment in the second-line setting.
Cabozantinib Plus Atezolizumab Moves Toward Regulatory Filing in High-Risk mCRPC
May 25th 2021Promising results from a phase 1b trial of cabozantinib in combination with atezolizumab for patients with high-risk, locally advanced or metastatic castration-resistant prostate cancer are expected to lead to regulatory submission.
FDA Grants Approval to Nivolumab as Adjuvant Treatment of Resected Esophageal/GEJ Cancer
May 20th 2021Adjuvant nivolumab for resected esophageal or gastroesophageal junction cancer was granted full approval by the FDA based on statistically significant improvements in disease-free survival over placebo in a phase 3 trial.
Sintilimab Moves Forward With FDA Acceptance of Application in Nonsquamous NSCLC
May 18th 2021Based on results of a phase 3 trial demonstrating the superiority of sintilimab versus placebo plus chemotherapy for nonsquamous non–small cell lung cancer, the FDA considers approval of the PD-1 inhibitor injection.