Plinabulin Plus Docetaxel Combination Succeeds in Improving OS in NSCLC With EGFR Wild Type
August 4th 2021The combination of plinabulin with docetaxel showed improvement in overall survival compared with docetaxel alone as treatment of patients with second- and third-line non –small cell lung cancer with EGFR wild type, meeting the primary end point of the phase 3 DUBLIN-3 clinical trial.
FDA Grants Priority Review to BLA for Adjuvant Atezolizumab in PD-L1+ NSCLC
August 3rd 2021The FDA has accepted the supplemental biologics license application submitted for atezolizumab as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer whose tumors express PD-L1≥1%, as determined by an FDA-approved test and granted it priority review.
Ivosidenib Plus Azacitidine Shows EFS Benefit in IDH1+ Acute Myeloid Leukemia
August 2nd 2021Treatment with ivosidenib tablets in combination with azacitidine led to improvement in event-free survival in patients with previously untreated IDH1-mutated acute myeloid leukemia, meeting the primary end point of the phase 3 AGILE study.
ATP128 With or Without Ezabenlimab Shows Early Promise in Stage IV Colorectal Cancer
August 1st 2021Preliminary results from the phase 1b KISIMA-01 indicate that combining the single chimeric fusion protein ATP128 with the PD-1 inhibitor, ezabenlimab, is tolerable in patients with heavily pretreated refractory stage IV colorectal cancer and may induce immune responses.
SEQUOIA Study Update: Zanubrutinib Prolongs PFS in Chronic Lymphocytic Leukemia
July 30th 2021Treatment with zanubrutinib in patients with treatment-naive chronic lymphocytic leukemia led to a significant improvement in progression-free survival, meeting the primary end point of the phase 3 SEQUOIA clinical trial.
FDA Grants Fast Track Designation to Novel Asparaginase Therapy for ALL Subset
July 30th 2021Fast track designation has been granted by the FDA to eryaspase for the treatment of patients with acute lymphocytic leukemia who have developed hypersensitivity reactions to E. coli-derived pegylated asparaginase.
FDA Warns of Death Risk in Ongoing Multiple Myeloma Clinical Trial
July 29th 2021A warning from the FDA highlights that an increased rate of death has been observed in patients with multiple myeloma who are undergoing treatment with the FDA-approved agent melphalan flufenamide in combination with dexamethasone in the phase 2 OCEAN clinical trial.
NRG-GY012 Study in Recurrent or Metastatic Endometrial Cancer Adds Treatment Arms
July 29th 2021In an interview with Targeted Oncology, Bobbie J. Rimel, MD, discussed the phase 2 NRG-GY012 results and the next step for cediranib plus olaparib as treatment of recurrent or metastatic endometrial cancer.
Study Explores Anti-PVRIG Therapy Plus Nivolumab and Anti-TIGIT Therapy in Advanced Solid Tumors
July 28th 2021The first patient with an advanced solid tumor has been dosed with the first-in-class anti-PVRIG antibody, COM701, in combination with nivolumab and the anti-TIGIT antibody, BMS-986207, in a phase 1/2 clinical trial.
PROs Offer More Insight on Tolerability of Adavosertib and Gemcitabine to Guide Phase 3 Trial
July 27th 2021In an interview with Targeted Oncology, Ainhoa Madariaga, MD, explained the similarities between the primary and exploratory analyses of adavosertib and gemcitabine in patients with ovarian cancer as it relates to toxicity.
Managing PARP Inhibitor Toxicities and Other Challenges in Community-Based Gynecologic Oncology
July 27th 2021In an interview with Targeted Oncology, Melissa M. Hardesty, MD, explained the state of gynecologic oncology treatment for rural patients in Alaska and how research is finding answers for improving clinical outcomes.
FDA Approves Pembrolizumab and Chemotherapy for High-risk Early-Stage TNBC
July 27th 2021The FDA has granted approval to pembrolizumab for the treatment of patients with high-risk early-stage triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery.
Mogamulizumab Improves Survival and Responses in Cutaneous T-cell Lymphoma With Blood Involvement
July 26th 2021Treatment with mogamulizumab-kpkc in adult patients with cutaneous T-cell lymphoma, including mycosis fungoides or Sézary syndrome, demonstrated better outcomes in those who had higher levels of blood involvement at baseline assessment, according to results of a post-hoc analysis for the MAVORIC trial.
FDA Denies Approval of Retifanlimab for Locally Advanced or Metastatic SCAC Subgroup
July 26th 2021The FDA issued a complete response letter to Incyte Corporation in response to the Biologics License Application for the PD-L1 inhibitor, retifanlimab for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal who have progressed on, or who are intolerant of, platinum-based chemotherapy.
Eprenetapopt With Azacitidine Demonstrates Efficacy in TP53-Positive MDS and AML
July 23rd 2021Eprenetapop combined with azacitidine has shown positive efficacy as post-transplant maintenance therapy for patients with TP53-mutant myelodysplastic syndrome and acute myeloid leukemia treated in a phase 2 study.
Overall Survival Results of I/O Combinations Differ Across Risk Groups of Metastatic RCC
July 22nd 2021The overall survival benefit of immunotherapy combinations compared with sunitinib for the treatment of patients with metastatic renal cell carcinoma who have favorable risk may differ from those who have intermediate or poor risk, according to a pooled analysis of frontline combination therapy conducted by the FDA.
FDA Breakthrough Therapy Designation Granted to Venetoclax/Azacitidine for Treatment-Naïve MDS
July 21st 2021The FDA has granted breakthrough therapy designation to the combination of venetoclax and azacitidine for the treatment of adult patients with previously untreated intermediate-, high- and very high-risk myelodysplastic syndromes.
Prospective Findings of TTFields/Sorafenib in Advanced HCC May Warrant a Randomized Study
July 16th 2021In an interview with Targeted Oncology, HEPANOVA EF-30 investigator, Eleni Gikka, MD, provided insight into the use of TTFields in combination with standard of care therapy for patients with advanced hepatocellular carcinoma.
FDA Lifts Partial Clinical from Study of RVU120 in Relapsed/Refractory AML and MDS
July 15th 2021The FDA has lifted its partial clinical hold on a phase 1B study of RVU120, which is an investigation of the agent for the treatment of patients with relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome.
FDA Approves Daratumumab Triplet for Previously Treated Multiple Myeloma
July 12th 2021The FDA has granted approval to the combination of daratumumab and hyaluronidase-fihj and pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.