Editor, OncLive®
Caroline Seymour is your initial point of contact for the OncLive® podcast, OncLive On Air™. She joined the company in 2018 as an assistant editor, with expertise in video production and print/digital publication. Email: cseymour@onclive.com
European Commission Approves Melphalan Flufenamide for Relapsed/Refractory Multiple Myeloma
August 18th 2022The European Commission has approved melphalan flufenamide for use in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 3 prior therapies.
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Trastuzumab Deruxtecan Improves PFS, OS in T-DM1–Pretreated HER2+ Metastatic Breast Cancer
August 15th 2022Trastuzumab deruxtecan led to a statistically significant improvement in progression-free survival and overall survival vs treatment with physician’s choice in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine.
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Panitumumab Plus mFOLFOX6 Improves Survival in RAS Wild-Type mCRC
August 12th 2022Treatment with frontline panitumumab and mFOLFOX6 led to a significant improvement in overall survival, plus higher response rates and R0 resection rates, compared with bevacizumab and mFOLFOX6 in patients with RAS wild-type metastatic colorectal cancer.
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Updated NCCN Guidelines Grant Tivozanib Category 1 Status for Pretreated RCC
August 10th 2022The Kidney Cancer Treatment guidelines, housed within the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology, have been revised, granting tivozanib Category 1 status as a subsequent therapy for patients with renal cell carcinoma who have received at least 2 prior lines of treatment.
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Amivantamab/Lazertinib/Chemo Combo Achieves 50% ORR in Pretreated EGFR-Mutant NSCLC
August 8th 2022Amivantamab in combination with lazertinib plus carboplatin and pemetrexed elicited encouraging responses in pretreated patients with EGFR-mutant non–small cell lung cancer, according to findings from the phase 1 CHRYSALIS-2 trial.
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Sotorasib Plus SHP2 Inhibition Elicits Promising Preliminary Activity in KRAS G12C–Mutated NSCLC
August 7th 2022The combination of sotorasib and the small molecule SHP2 inhibitor RMC-4630 led to an investigator-assessed objective response rate of 27% and 50% in pretreated and KRAS G12C inhibitor–naïve patients with non–small cell lung cancer, respectively.
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REGN5678 Plus Cemiplimab Demonstrates Early Activity in mCRPC
August 3rd 2022The novel PSMAxCD38 costimulatory bispecific antibody REGN5678 has shown encouraging efficacy in combination with cemiplimab in patients with advanced metastatic castration-resistant prostate cancer, according to preliminary findings from an ongoing phase 1/2 trial (NCT03972657).
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Pembrolizumab Plus Chemotherapy Fails to Improve OS, Radiographic PFS in mCRPC
August 3rd 2022Pembrolizumab plus docetaxel failed to elicit a statistically significant improvement in overall survival and radiographic progression-free survival in patients with metastatic castration-resistant prostate cancer, missing the coprimary end points of the phase 3 KEYNOTE-921 trial.
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FDA Grants Fast Track Designation to OP-1250 in ER+/HER2- Metastatic Breast Cancer
August 2nd 2022The FDA has granted a fast track designation to OP-1250 for the treatment of patients with ER-positive, HER2- metastatic breast cancer who have progressed following at least 1 line of endocrine therapy with at least 1 line administered in combination with a CDK4/6 inhibitor.
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FDA Accepts BLA for N-803 in BCG-Unresponsive Non–Muscle Invasive Bladder Cancer in Situ
August 1st 2022The FDA has accepted for review a biologics license application for the IL-15 superagonist N-803 for the treatment of patients with Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer carcinoma in situ.
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With two highly selective and active RET inhibitors approved for use in patients with metastatic RET alteration–positive non–small cell lung cancer, the dilemma is not determining which agent to select but ensuring that next-generation sequencing is done up front and in the presence of acquired resistance.
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PC14586 Shows Preliminary Activity, Safety in p53 Y220C–Mutant Solid Tumors
July 28th 2022The first-in-class p53 reactivator, PC14586, induced a response in approximately 1 of 4 patients with advanced solid tumors harboring p53 Y220C mutations and showcased an acceptable safety profile consisting primarily of grade 1 and 2 events.
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IRX-2 Immunotherapy Misses EFS End Point in Newly Diagnosed Head and Neck Cancer
July 27th 2022IRX-2 failed to demonstrate a statistically significant improvement in event-free survival as neoadjuvant therapy compared with standard of care in patients with newly diagnosed, stage II, III, or IVA squamous cell carcinoma of the oral cavity.
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CHMP Recommends Restricting Third-Line Rucaparib Use in BRCA+ Ovarian Cancer
July 25th 2022The European Medicines Agency Committee for Medicinal Products for Human Use has recommended that rucaparib no longer be used as monotherapy for the third-line treatment of patients with platinum-sensitive, relapsed or progressive BRCA-mutated high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer.
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FDA Grants Priority Review to Trastuzumab Deruxtecan for HER2-Low Metastatic Breast Cancer
July 25th 2022The FDA has accepted and granted priority review to a supplemental biologics license application for the use of trastuzumab deruxtecan in the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received 1 prior therapy in the metastatic setting.
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Zanubrutinib Displays Improved Efficacy Vs Orelabrutinib in Relapsed/Refractory CLL/SLL and MCL
July 22nd 2022Zanubrutinib demonstrated a significant improvement in progression-free survival compared with orelabrutinib in patients with relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma or mantle cell lymphoma.
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Pembrolizumab Plus Chemoradiation Misses EFS End Point in Head and Neck Squamous Cell Carcinoma
July 20th 2022Pembrolizumab plus concurrent chemoradiation followed by pembrolizumab maintenance did not lead to a statistically significant improvement in event-free survival vs concurrent chemoradiation alone in patients with unresected locally advanced head and neck squamous cell carcinoma.
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The combination of ofranergene obadenovec and paclitaxel failed to elicit a statistically significant improvement in progression-free survival or overall survival compared with paclitaxel alone in patients with platinum-resistant ovarian cancer, missing the coprimary end points of the OVAL trial.
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Neratinib-based combinations, antibody-drug conjugates, and bispecific antibodies represent novel and effective treatment options for patients with pretreated HER2-mutant and HER2-low metastatic breast cancer, but the successful integration of these regimens into care will require further investigation into current definitions of HER2 positivity.
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FDA Removes Clinical Hold on FLAMINGO-01 Trial in High-Risk HER2/Neu-Positive Breast Cancer
July 12th 2022The FDA has removed the clinical hold on the phase 3 FLAMINGO-01 trial allowing the study to continue elevating the activity and safety of the HER2/neu-peptide GLSI-100 in patients with HER2/neu-positive breast cancer who are at high risk for disease recurrence or have residual disease following completion of neoadjuvant and adjuvant trastuzumab-based therapy, according to an announcement from the drug developer.
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FDA Accepts BLA for Trastuzumab Duocarmazine for Advanced HER2+ Breast Cancer
July 12th 2022The FDA has accepted for review a biologics license application for vic-trastuzumab duocarmazine for the treatment of patients with HER2-positive unresectable locally advanced or metastatic breast cancer.
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Nivolumab Plus Ipilimumab Displays Durable Benefit in MSI-H/dMMR mCRC
July 8th 2022Nivolumab alone or in combination with ipilimumab continued to demonstrate sustained clinical benefit as second- and first-line therapy, respectively, in patients with microsatellite instability–high and mismatch repair deficient metastatic colorectal cancer.
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Neoadjuvant Nivolumab Plus Ipilimumab Elicits 100% Response Rate in dMMR Colon Cancer
July 8th 2022The combination of nivolumab and ipilimumab generated a 100% response rate in patients with mismatch repair–deficient colon cancer and a 29% response rate in patients with MMR-proficient disease.
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FDA Grants Fast Track Designation to Belzupacap Sarotalocan for Non–Muscle Invasive Bladder Cancer
July 7th 2022The FDA has granted a fast track designation to belzupacap sarotalocan for the treatment of patients with non–muscle invasive bladder cancer, representing the first virus-like drug conjugate candidate therapy from Aura Biosciences, Inc., the drug developer.
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