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.
Investigators Set Sights on Immunotherapy for Long-Term Disease Control in NSCLC
June 9th 2023Stephen V. Liu, MD, highlighted the importance of next-generation sequencing in lung cancer, key trials that have shifted the non–small cell lung cancer treatment landscape, and detailed ongoing research at Georgetown University Lombardi Comprehensive Cancer Center.
Resection Should be Considered for Residual Non-Retroperitoneal Disease in Post-Chemo NSGCTs
June 8th 2023Although patients with metastatic nonseminomatous germ-cell tumors who had teratoma in the primary tumor were found to have a higher rate of teratoma in residual non-retroperitoneal disease following chemotherapy, those without teratoma in the primary tumor could have teratoma or active testicular germ-cell tumors in residual disease post-chemotherapy and should be considered for resection.
FDA Lifts Partial Clinical Hold on Phase 1 Trial of MT-0169 in Multiple Myeloma, Hodgkin Lymphoma
June 8th 2023The FDA has removed a partial clinical hold that had been placed on a phase 1 trial investigating the safety and efficacy of MT-0169 as a potential therapeutic option in patients with relapsed or refractory multiple myeloma or non-Hodgkin lymphoma.
A2B530 Harnesses Unique Mechanism of Action to Integrate CAR T in Solid Tumors
June 8th 2023Looking to replicate the impressive findings with CAR T-cell therapies observed in patients with hematologic malignancies, investigators have initiated the BASECAMP-1 trial with the hope of identifying patients with advanced solid tumors who will be suitable candidates for treatment in the EVEREST trial.
FDA Approval Sought for Pembrolizumab Plus Chemotherapy in Biliary Tract Cancer
June 8th 2023The FDA has accepted for review a supplemental biologics license application seeking the approval of pembrolizumab plus standard chemotherapy comprised of gemcitabine and cisplatin for use in patients with locally advanced unresectable or metastatic biliary tract cancer.
Neoadjuvant Durvalumab Plus Chemo Improves pCR Vs Chemo Alone in Gastric and GEJ Cancers
June 8th 2023The addition of durvalumab to standard neoadjuvant chemotherapy significantly improved pathologic complete response over neoadjuvant chemotherapy alone in patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers.
FDA Extends Review Period for Nirogacestat NDA in Desmoid Tumors
June 8th 2023The FDA has extended the Prescription Drug User Fee Act decision date by 3 months to allow more time to complete their review of the new drug application seeking the approval of nirogacestat in the treatment of adult patients with desmoid tumors.
Majority of US Cancer Centers Report Shortages of Cisplatin/Carboplatin Chemotherapy
June 7th 2023A survey conducted by the National Comprehensive Cancer Network Best Practices Committee found that 93% of United States cancer centers polled in the report are experiencing a shortage of carboplatin, and 70% currently have a shortage of cisplatin.
Nivolumab Plus Relatlimab Demonstrates Consistent Benefit for Patients with Advanced Melanoma
June 7th 2023Two-year follow-up data from the RELATIVITY-047 trial showed a continued benefit for patients with previously untreated, unresectable, or metastatic melanoma receiving nivolumab plus relatlimab vs nivolumab monotherapy supporting the use of the combination.
FDA Approval Sought for Cilta-cel in Relapsed and Lenalidomide-Refractory Multiple Myeloma
June 7th 2023A supplemental biologics license application seeking the approval of ciltacabtagene autoleucel for use in adult patients with relapsed and lenalidomide-refractory multiple myeloma who have previously received at least 1 line of therapy, including a proteasome inhibitor and an immunomodulatory agent, has been submitted to the FDA.
BL-B01D1 Demonstrates Antitumor Activity in EGFR+ NSCLC and Other Solid Tumors
June 7th 2023The first-in-class EGFR x HER3 bispecific antibody-drug conjugate BL-B01D1 generated antitumor activity and safety in patients with advanced solid tumors, particularly EGFR-mutated and wild-type non–small cell lung cancer and nasopharyngeal carcinoma.
Dabrafenib and Trametinib Plus Navitoclax Meets CR End Point in BRAF V600–mutant Metastatic Melanoma
June 7th 2023The combination of dabrafenib and trametinib plus navitoclax generated responses and met the co-primary end point for complete response rate vs historical controls in patients with BRAF V600–mutant metastatic melanoma.
TTFields Plus SOC Improves OS in Metastatic NSCLC After Progression on Platinum-based Chemotherapy
June 6th 2023The addition of tumor treating fields to standard-of-care immunotherapy or chemotherapy regimens elicited an improvement in overall survival vs SOC therapies alone in patients with metastatic non-small cell lung cancer following progression on or after platinum-based chemotherapy, according to data from the phase 3 LUNAR trial.
Liso-Cel Leads to Rapid Responses, High Undetectable MRD Rates in Relapsed/Refractory CLL/SLL
June 6th 2023Treatment with lisocabtagene maraleucel elicited encouraging responses regardless of prior progression on BTK inhibition or absence of clinical benefit with venetoclax in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, meeting the primary end point of the phase 1/2 TRANSCEND CLL 004 trial.
mRNA-4157 Plus Pembrolizumab Improves DMFS in High-Risk Melanoma
June 6th 2023The combination of mRNA-4157 and pembrolizumab reduced the risk of developing distant metastasis or death by approximately 65% compared with pembrolizumab alone as adjuvant therapy in patients with resected melanoma at high risk of recurrence, according to findings from the phase 2 KEYNOTE-942 trial.
Datopotamab Deruxtecan Plus Pembrolizumab With or Without Chemo Produces Responses in Advanced NSCLC
June 6th 2023Combination treatment consisting of datopotamab deruxtecan and pembrolizumab with or without platinum-based chemotherapy generated responses as first- or second-line treatment for patients with advanced or metastatic non–small cell lung cancer.
Sunvozertinib Demonstrates Antitumor Activity and Tolerability in EGFR Exon 20–mutated NSCLC
June 6th 2023The novel irreversible EGFR exon 20 insertion inhibitor sunvozertinib demonstrated significant clinical activity and similar safety to prior reports in Chinese patients with non–small cell lung cancer harboring EGFR exon 20 insertion mutations who progressed on prior platinum-based chemotherapy, according to results from the phase 2 WO-KONH6 study.
Pembrolizumab Plus Chemo Does Not Significantly Improve Survival in TKI-resistant, EGFR+ NSCLC
June 6th 2023The addition of pembrolizumab to pemetrexed and platinum-based chemotherapy resulted in a numerical, but not statistically significant, improvement in progression-free survival or overall survival vs chemotherapy plus placebo in patients with TKI-resistant, EGFR-mutated, metastatic nonsquamous non–small cell lung cancer.
Avutometinib Plus Defactinib Demonstrates Promising Activity in Recurrent LGSOC
June 6th 2023Treatment with avutometinib plus defactinib elicited high responses among patients with recurrent low grade serous ovarian cancer compared with avutometinib monotherapy, supporting the use of the combination in this patient population regardless of KRAS status, according to data from the RAMP 201 trial.
FDA Grants Priority Review to Dostarlimab Plus Chemo for dMMR/MSI-H Endometrial Cancer
June 6th 2023The FDA has accepted and granted priority review to a supplemental biologics license application seeking the approval of dostarlimab plus chemotherapy for use in adult patients with mismatch repair–deficient/microsatellite instability–high primary advanced or recurrent endometrial cancer.