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FDA Approves Cemiplimab in Frontline PD-L1-High Advanced NSCLC
February 22nd 2021The FDA has granted approval to cemiplimab-rwlc, for the first-line treatment of patients with advanced non-small cell lung cancer whose tumors have high PD-L1 expression, as determined by an FDA-approved test. Patients must either have metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation, and the tumors must not have EGFR, ALK, or ROS1 aberrations.
Axi-Cel Shows Activity in Relapsed/Refractory DLBCL Regardless of Chemo Sensitivity
February 22nd 2021Data from patients with relapsed/refractory diffuse large B-cell lymphoma treated with axicabtagene ciloleucel showed that post-chimeric antigen receptor T outcomes may not correlate with responsiveness observed with treatment received immediately prior.
Adjuvant Imatinib Confirmed Beneficial for RFS in High-Risk Gastrointestinal Stromal Tumors
February 20th 2021Adjuvant imatinib has demonstrated significant improvement in relapse-free survival over a 2-year period and a mild trend toward long-term improvement in failure-free survival as treatment of patients with high-risk gastrointestinal stromal tumors, according to 9.1-year follow-up results from a randomized phase 3 study.
FDA-Approved Advanced GIST Therapy Can Elicit Durable Responses With Tolerable Safety
February 20th 2021In patients with gastrointestinal stromal tumors who have received 3 or more prior therapies, there remain unmet needs to overcome resistance to the standard-of-care, imatinib, a tyrosine kinase inhibitor, and prolong the 6.3-month+ progression-free survival achieved with the FDA-approved TKI ripretinib.
Neoadjuvant Cabozantinib/Nivolumab Feasible For Borderline Resectable Patients with HCC
February 19th 2021Preliminary data showing the neoadjuvant use of cabozantinib and nivolumab to be feasible for borderline resectable patients with hepatocellular carcinoma that can lead to potentially curative resection.
Invasive GIST Originating in the Stomach/Small Intestine Is More Common in Men, Study Shows
February 19th 2021Men appear to be more likely than women to have invasive gastrointestinal stromal tumors originating in the stomach and small intestines. For treatment, an expert says that combined surgery and systemic therapy demonstrates the best outcomes.
Precision Medicine Shapes the Future of Follicular Lymphoma Management
February 19th 2021In an interview with Targeted Oncology, Carla Casulo, MD, discussed the modern management of patients with relapsed/refractory follicular lymphoma. She also explained how ongoing research may shape the future of the field.
Addition of Daratumumab to Rd/Vd Heightens MRD Negativity Rates in R/R Myeloma
February 18th 2021High rates of sustained MRD negativity were achieved with daratumumab-containing combinations compared with the standard-of-care combinations, according to an exploratory analysis of 2 ongoing clinical trials.
Developers Submit BLAs for Enfortumab Vedotin for 2 Urothelial Carcinoma Indications
February 18th 2021The submission of 2 Biologic License Applications for enfortumab vedotin-ejfv have been made to the FDA for consideration as treatment of patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and who are ineligible for cisplatin.
Phase 2 Study of VAL-083 Trial Reaches Target Enrollment of Patients With Glioblastoma Multiforme
February 18th 2021The final patient with glioblastoma multiforme has been enrolled in the ongoing phase 2 clinical trial of VAL-083, which is evaluating the efficacy, safety, and pharmacokinetics of the agent in patients who have been pre-treated with temozolomide prior to disease recurrence.
The Efficacy of Ibrutinib Plus Venetoclax for the Treatment of R/R MCL
February 18th 2021Constantine Tam, MD, discuses the outcomes of the phase 3 Sympatico Study, which evaluated the safety and efficacy of ibrutinib (Imbruvica) plus venetoclax (Venclexta) for the treatment of relapsed or refractory mantle cell lymphoma compared to monotherapy.
NeoADAURA Trial Launches With Plans to Assess Neoadjuvant Osimertinib in Resectable EGFR+ NSCLC
February 18th 2021n patients with resectable, stage II-IIIB non–small cell lung cancer whose tumors harbor EGFR mutations, neoadjuvant osimertinib will be administered as a single agent or in combination with platinum-based chemotherapy compared with chemotherapy alone in the NeoADAURA trial
FDA Grants Priority Review to Vicineum for High-Risk, BCG-Unresponsive NMIBC
February 17th 2021The FDA has accepted a Biologic License Application for Vicineum as a treatment option for patients with high-risk, Bacillus Calmette-Guerin-unresponsive non–muscle invasive bladder cancer, and granted it Priority Review,.
Nivolumab Plus Ipilimumab Improves Survival, Shows Activity in Sarcomatoid RCC
February 17th 2021The immunotherapy combination of nivolumab and ipilimumab has improved survival and response rates compared with sunitinib, in patients with advanced renal cell carcinoma with sarcomatoid histology, including those with intermediate and poor-risk features.
FDA Grants Sotorasib a Priority Review for KRAS G12C+ Advanced NSCLC
February 17th 2021The FDA accepted a new drug application for sotorasib and granted it a priority review for the treatment of patients with KRAS G12C–mutant locally advanced or metastatic non–small cell lung cancer following at least 1 prior systemic treatment.
Off-the-Shelf NK Immunotherapy Is Safe and Promising in B-Cell NHL With Chemotherapy and Transplant
February 16th 2021Early antitumor activity was seen with cord blood–derived natural killer immunotherapy in combination with high-dose chemotherapy and autologous stem cell transplant in patients with B-cell non-Hodgkin lymphoma, according to early results from a phase 2 trial.
18F-DCFPyL, PSMA-Targeted PET Imaging Agent, Provokes High CLR and PPV
February 13th 2021Localized metastatic lesions were detected with a high correct localization rate (CLR) and positive predictive value (PPV) with the investigational prostate-specific membrane antigen (PSMA)–targeted PET imaging agent 18F-DCFPyL.