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.
CAR T-cell Coadministration Strengthens Responses in Childhood B-cell ALL
November 15th 2022The coadministration of CD19 and CD22 CAR T-cell therapy elicited promising responses and event-free survival rates in pediatric patients with relapsed or refractory B-cell acute lymphoblastic leukemia, according to findings from a phase 2 trial.
Frontline Eganelisib Triplet Provides Potential Long-term PFS Benefit in Metastatic TNBC
November 15th 2022The addition of eganelisib to atezolizumab and nab-paclitaxel demonstrated evidence of a long-term progression-free survival benefit when used as first-line treatment in patients with metastatic triple-negative breast cancer according to updated data from the phase 2 MARIO-3 trial.
FDA Approves First IHC Companion Diagnostic for Mirvetuximab Soravtansine in Ovarian Cancer
November 15th 2022The FDA has approved the VENTANA FOLR1 RxDx assay, the first immunohistochemistry companion diagnostic test to help identify patients with epithelial ovarian cancer who are eligible for treatment with mirvetuximab soravtansine-gynx.
Second-line Fruquintinib Plus Paclitaxel Improves PFS in Chinese Patients With Gastric Cancer
November 15th 2022The addition of fruquintinib to paclitaxel in the second-line treatment of Chinese patients with advanced gastric or gastroesophageal junction adenocarcinoma significantly improved progression-free survival over paclitaxel alone.
Multidisciplinary Workflow Benefits Patients With Newly Diagnosed Pancreatic Cancer
November 15th 2022Early experience with a newly designed pancreatic cancer multidisciplinary clinic workflow at Roswell Park Comprehensive Cancer Center in Buffalo, New York, showed significant improvement in terms of time to subspecialty evaluation.
FDA Approves Mirvetuximab Soravtansine-gynx for FRα+ Platinum-resistant Ovarian Cancer
November 14th 2022The FDA has granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere) for the treatment of select patients with folate receptor α–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Checkpoint Inhibitor Challenges Warrant Consideration for a Targeted Approach in NSCLC
November 14th 2022In treating patients with locally advanced non–small cell lung cancer, one must consider multiple factors when deciding whether to treat them with immunotherapy or a targeted approach, even though the optimal treatment sequence has yet to be definitively established.
Olaparib Combo Approaches EU Approval for Select Patients With mCRPC
November 14th 2022The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of olaparib in combination with abiraterone acetate and prednisone or prednisolone for use in adult patients with metastatic castration-resistant prostate cancer in whom chemotherapy is not indicated.
Osimertinib Remains the Preferred Frontline Choice for EGFR-Mutated NSCLC
November 14th 2022Osimertinib remains the preferred first-line therapy for patients with EGFR-mutated non–small cell lung cancer. However, for those with classic EGFR mutations, the day is fast approaching when physicians will add chemotherapy to first-line treatment with the EGFR TKI based on ctDNA results.
Targeting the ‘New Kids on the Block’ in NSCLC: EGFR Exon 20 and MET Exon 14 Skipping Mutations
November 14th 2022Investigators are harnessing comprehensive molecular profiling to detect new targets, optimize existing treatment regimens, and develop novel therapies for patients with EGFR and MET exon 20–insertion positive non–small cell lung cancer.
FDA Requests Restriction of Second-line Maintenance Niraparib Indication in Ovarian Cancer
November 14th 2022At the request of the FDA, GlaxoSmithKline plc will restrict the second-line maintenance indication for niraparib to only the population of patients with recurrent ovarian cancer whose tumors harbor deleterious or suspected deleterious germline BRCA mutations.
European Commission Recommends Trastuzumab Deruxtecan Approval for Pretreated HER2+ Gastric Cancer
November 14th 2022The European Medicines Agency’s CHMP has recommended the approval of trastuzumab deruxtecan as monotherapy for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.
Basket Trial Investigates Nab-Sirolimus for Treatment of TSC1/2 Mutations
November 14th 2022With no approved agents for patients with malignant tumors harboring TSC1 or TSC2 inactivating alterations, investigators seek to establish a new pathway forward for patients with solid tumors in the PRECISION 1 trial.
CYNK-101 Plus Avelumab Mediates ADCC Activity in Select PD-L1+ Solid Tumors
November 13th 2022CYNK-101 demonstrated synergistic activity when used in combination with avelumab through antibody-dependent cellular cytotoxicity against PD-L1–positive non–small cell lung cancer, triple-negative breast cancer, and bladder cancer cell lines, according to preclinical data.
Prostate Cancer Has High Rate of Actionable Mutations, Underscoring Need for Testing
November 12th 2022All patients with prostate cancer, except for those with low-risk or very low-risk localized disease, should be tested for germline mutations, and somatic testing should be done in all patients with metastatic disease as there are therapeutic implications.
Sequencing Considerations in mCRPC Treatment Grow Increasingly Complex
November 11th 2022For patients with metastatic castration-resistant prostate cancer who experience disease progression on novel hormonal agents (NHAs) and androgen deprivation therapy, it is important to consider when the NHA was received and whether docetaxel has been administered, as these factors affect downstream options and sequencing.
Genetic Testing Proves Significant in Identifying Somatic and Germline Mutations in Prostate Cancer
November 11th 2022As the role of genetic testing in clinical practice becomes more prevalent for patients with prostate cancer to identify mutations, physicians must consider a variety of factors to determine which patients are candidates for somatic and/or germline testing.
CTX130 Allogeneic CAR T-cell Therapy Shows Tolerability, Intriguing Activity in Advanced RCC
November 11th 2022CTX130, an investigational allogeneic, CRISP/Cas9 gene-edited, anti-CD70 CAR T-cell therapy, was found to be safe with early signs of clinical activity in patients with advanced clear cell renal cell carcinoma, according to findings from the phase 1 COBALT-RCC trial.
Pembrolizumab/Eftilagimod alpha Combo Shows Durable Responses in Frontline NSCLC
November 11th 2022The first-line combination of pembrolizumab and eftilagimod alpha elicited a 40.4% (95% CI, 31.3%-50.0%) overall response rate by immune RECIST criteria in the intent-to-treat population in patients with advanced non–small cell lung cancer, according to updated findings from the phase 2 TACTI-002 trial.
FDA Approves Tremelimumab Plus Durvalumab and Chemo for Metastatic NSCLC
November 10th 2022The FDA has approved tremelimumab-actl (Imjudo) plus durvalumab (Imfinzi) and platinum-based chemotherapy for adult patients with metastatic non–small cell lung cancer without sensitizing EGFR mutation or ALK aberrations.
Every Patient With Metastatic Melanoma “Deserves a Shot at Nivolumab/Ipilimumab,” Weber Says
November 10th 2022The combination of nivolumab and ipilimumab have shown overall survival benefit in patients with metastatic melanoma, according to long-term follow-up data, and other studies’ results highlight the efficacy and toxicity benefits of different sequences of the combination.