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FDA Releases New Guidance on MFS as a Primary End Point for Prostate Cancer Trials
August 11th 2021Metastasis-free survival can be an effective end point in clinical trials to support approval of castration-resistant prostate cancer therapies under certain conditions when overall survival is not feasible as an end point.
Community Oncology Professionals Highlight Need for More Education on Immunotherapies
August 11th 2021The Association of Community Cancer Centers released the results of their 2020 ACCC IO survey that showed how oncology professionals are looking to understand and take advantage of the growing immunotherapy treatment landscape.
Mirvetuximab May Replace Paclitaxel as Standard Therapy for High FRα-Expressing Ovarian Cancer
August 11th 2021In an interview with Targeted Oncology™, David O’Malley, MD, discussed the results from an arm of the phase 2 study of 5 mirvetuximab-containing regimens that were evaluated for the treatment of patients with FRα-positive ovarian cancer.
I/O Vaccine Maveropepimut-S Shows Encouraging Results in Advanced Recurrent Ovarian Cancer
August 11th 2021Outcomes in patients with advanced recurrent ovarian cancer treated with the novel immunotherapeutic vaccine maveropepimut-S appeared encouraging, according to topline results from the DeCidE1 clinical trial.
Trastuzumab and Chemotherapy Could Reduce Early-Stage HER2-Positive Breast Cancer Deaths by a Third
August 10th 2021The addition of trastuzumab to chemotherapy for the treatment of early-stage, HER2-positive breast cancer helps to reduce disease recurrence and can potentially reduce the mortality from breast cancer by a third worldwide.
Sintilimab/Chemotherapy Shows Sustained Survival Benefit in Nonsquamous NSCLC
August 10th 2021A significantly longer overall survival was achieved with the human IgG4 monoclonal antibody sintilimab in patients with locally advanced or metastatic nonsquamous non–small cell lung cancer treated in the phase 3 ORIENT-11 clinical trial.
FDA Accepts sBLA for Pembrolizumab Monotherapy for Endometrial Cancer
August 10th 2021The FDA has accepted a new supplemental biologics license application for pembrolizumab, an anti-PD-1 therapy, as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, who have diseased progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
FDA Grants Priority Review to sBLA for Adjuvant Pembrolizumab in RCC
August 10th 2021The FDA has accepted a supplemental biologics license application for adjuvant pembrolizumab and granted it priority review as a treatment for patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
Tucatinib, Trastuzumab, and Capecitabine Improve OS, PFS in HER+ Breast Cancer
August 9th 2021Guiseppe Curigliano, MD, discusses the design and results of the HER2CLIMB-02 study which evaluated the efficacy of tucatinib in combination with trastuzumab and capecitabine in HER2-positive breast cancer patients with and without brain metastases compared to placebo.
Polatuzumab Vedotin Combo Improves Outcomes in Previously Untreated DLBCL
August 9th 2021A significantly improved and clinically meaningful progression-free survival was accomplished by combining polatuzumab vedotin and R-CHOP in patients with previously untreated diffuse large B-cell lymphoma compared with R-CHOP alone, according to results of the phase 3 POLARIX trial.
Global Study Explores RAF/MEK/FAK Combo in Recurrent LGSOC, With or Without KRAS Mutations
August 6th 2021In an interview with Targeted Oncology™ following a presentation of the study protocol at the 2021 American Society of Clinical Oncology Annual Meeting, Susana K. Banerjee, PhD, explained the progress of ENGOT-ov60/GOG3052/RAMP 201 in detail.
Maintenance Vigil I/O Shows Efficacy in HRD-Proficient Advanced Ovarian Cancer
August 6th 2021Rodney P. Rocconi, MD, discusses a subgroup analysis of the phase 2b VITAL study in which the efficacy of maintenance Vigil immunotherapy is explored in patients with newly diagnose advanced ovarian cancer who are homologous recombination proficient.
Weill Cornell Medicine Becomes First to Test CAR T Cells in Patients With R/R Thyroid Cancer
August 6th 2021A non-randomized, open-label trial of AIC100, an autologous chimeric antigen receptor T-cell agent for the treatment of relapsed/refractory thyroid cancer, is currently recruiting patients at the Weill Cornell Medical College in New York, under the supervision of Koen van Besien, MD, PhD.
Eflapegrastim Still Not Approved by FDA After New Complete Response Letter
August 6th 2021The FDA has issued a complete response letter to the developer of eflapegrastim, for which a biologics license application was submitted for the treatment of chemotherapy-induced neutropenia. The FDA has cited manufacturing deficiencies and is requiring that the facilities be reinspected.
Trial of ARX517 Doses First Patient With a PSMA-Expressing Solid Tumor
August 5th 2021To address over expression of the prostate specific membrane antigen in men with prostate cancer and other solid tumors, a phase 1 study of the novel anti-PSMA antibody drug conjugate, ARX517, has been administered to the first patient.
Addition of Cemiplimab to Platinum-Doublet Chemotherapy Prolongs OS in Advanced NSCLC
August 5th 2021Patients with advanced non-small cell lung cancer treated with cemiplimab in combination with platinum-doublet chemotherapy saw an improvement in overall survival in comparison with patients who received chemotherapy alone, meeting the primary end point of the phase 3 EMPOWER-Lung 3 study.
FDA Grants Priority Review to Pembrolizumab for Stage IIB or IIC Melanoma
August 5th 2021The FDA has accepted and granted priority review to a biologics license application for pembrolizumab for the adjuvant treatment of adult and pediatric patients with stage IIB or IIC melanoma following complete resection.
Clinical Potential of onCARlytics Under Exploration in Solid Tumors
August 4th 2021Research in the solid tumors arena around the combination of the oncolytic virus technology CF33-CD19 and the CD19-targeting CAR placental-derived T-cell therapy CyCART-19, is underway to explore it’s potential in this patient population.