Managing 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
LEAP-010 Trial Discontinued After OS Projection With Pembrolizumab/Lenvatinib in Metastatic HNSCC
August 25th 2023The combination of pembrolizumab and lenvatinib demonstrated a statistically significant improvement in progression-free survival and objective response rate but failed to improve overall survival compared with pembrolizumab plus placebo as frontline therapy for patients with recurrent or metastatic head and neck squamous cell carcinoma.
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Olaparib Plus Abiraterone Acetate Receives Japanese Approval for BRCA-Mutant mCRPC
August 24th 2023The Japanese Ministry of Health, Labour, and Welfare has approved the combination of olaparib plus abiraterone acetate and prednisone or prednisolone for the treatment of adult patients with BRCA-mutated castration-resistant prostate cancer with distant metastasis.
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Tiragolumab Plus Atezolizumab Falls Short in Unexpected OS Analysis in PD-L1–High NSCLC
August 23rd 2023The addition of the investigational anti-TIGIT immunotherapy tiragolumab to atezolizumab demonstrated a numerical but not statistically significant improvement in overall survival vs atezolizumab alone as frontline therapy for patients with PD-L1–high, locally advanced or metastatic non–small cell lung cancer.
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Personalized Neoantigen Vaccine Induces Continued Responses in Pretreated, Advanced HCC
August 22nd 2023Second-line treatment with GNOS-PV02 plus plasmid-encoded interleukin-12 followed by electroporation elicited complete molecular response detected via circulating tumor DNA in 4 additional patients with advanced hepatocellular carcinoma enrolled in the phase 1b/2a GT-30 study.
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FDA Places Second Partial Clinical Hold on AML Enrollment for Magrolimab Trials
August 21st 2023The FDA has placed another partial clinical hold on the enrollment of new patients in United States clinical trials evaluating the potential first-in-class investigational anti-CD47 immunotherapy magrolimab for the treatment of acute myeloid leukemia.
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Atezolizumab Plus Cabozantinib Improves PFS in Hormone Therapy–Pretreated mCRPC
August 21st 2023The combination of cabozantinib and atezolizumab led to a statistically significant improvement in progression-free survival compared with a second novel hormonal therapy in patients with metastatic castration-resistant prostate cancer and measurable soft tissue disease following 1 prior novel hormonal therapy, meeting one of the primary end points in the primary analysis of the phase 3 CONTACT-02 trial.
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Belzutifan Improves PFS in Pretreated Advanced RCC
August 18th 2023Treatment with belzutifan demonstrated a statistically significant and clinically meaningful improvement in progression-free survivalcompared with everolimus in patients with advanced renal cell carcinoma that has progressed on prior PD-1/PD-L1 and VEGF inhibitors, in sequence or in combination.
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Frontline Quizartinib Plus Chemotherapy Shows Curative Potential in FLT3-ITD Wild-Type AML
August 17th 2023The addition of quizartinib to standard induction and consolidation chemotherapy with idarubicin plus cytarabine followed by maintenance therapy led to an improvement in event-free survival compared with placebo plus chemotherapy in patients with FLT3-ITD wild-type acute myeloid leukemia.
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Copper 64 PSMA I&T Meets Coprimary End Points of SOLAR Trial in Metastatic Prostate Cancer
August 15th 2023Use of Copper 64 PSMA I&T for PET/CT imaging met the threshold for significance regarding region-level correct localization rate and patient-level correct detection rate in patients with histologically confirmed metastatic prostate cancer, meeting the coprimary end points of the phase 2 SOLAR trial.
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Extended Treatment With CAEL-101 Plus SOC Therapy Proves Safe in Light-Chain Amyloidosis
August 12th 2023The addition of the chimeric monoclonal antibody CAEL-101 to standard therapy with cyclophosphamide, bortezomib, and dexamethasone with or without daratumumab demonstrated a manageable toxicity profile with prolonged clinical benefit in patients with amyloid light-chain amyloidosis.
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FDA Approves Niraparib Plus Abiraterone Acetate for BRCA+ mCRPC
August 11th 2023The FDA has approved niraparib plus abiraterone acetate, given with prednisone, for the treatment of adult patients with deleterious or suspected deleterious BRCA-positive, metastatic castration-resistant prostate cancer, as detected by an FDA-approved test.
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FDA Allows Continuation of Phase 1/2 Trial of ONCT-534 in mCRPC
August 11th 2023The FDA has approved a study may proceed letter in advance of its 30-day review period to Oncternal Therapeutics for its phase 1/2 study evaluating ONCT-534, a novel dual-action AR inhibitor in patients with mCRPC who have relapsed or are refractory to approved AR signaling inhibitors.
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Zipalertinib Plus Chemotherapy Moves to Phase 3 Study in EGFR Exon 20 Insertion+ NSCLC
August 4th 2023The safety and efficacy of zipalertinib plus platinum-based chemotherapy will be compared with platinum-based chemotherapy alone in patients with treatment-naïve, locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations in the phase 3 REZILIENT3 trial.
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FDA Issues CRL to BLA Resubmission for Remestemcel-L in Pediatric Steroid-Refractory aGVHD
August 4th 2023The FDA has released a complete response letter to its biologics license application resubmission, indicating that it needs more data to support approval for remestemcel-L for the treatment of pediatric patients with steroid-refractory acute graft-vs-host disease.
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Data With Novel Agents Prompt Treatment Sequencing Discussions in MCL and CLL
August 3rd 2023Catherine C. Coombs, MD, and Alexey Danilov, MD, PhD, moderate a discussion on the role and sequencing of BTK inhibitors, venetoclax-based regimens, and CAR T-cell therapy in mantle cell lymphoma and chronic lymphocytic leukemia.
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Prexigebersen–Based Therapy Induces High CR/CRi Rates in Newly Diagnosed, Relapsed/Refractory AML
August 1st 2023Prexigebersen in combination with decitabine and venetoclax demonstrated potent antitumor activity when used in the treatment of patients with newly diagnosed and relapsed/refractory acute myeloid leukemia.
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Several Research Avenues Are Available for Improving Response to Immunotherapy in Advanced NSCLC
July 29th 2023Tony S.K. Mok, MD, BMSc, FRCPC, FASCO, highlights novel partners and potential new approaches for immunotherapy-based regimens for the treatment of patients with non–small cell lung cancer.
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New agents in development including ABBV-011 and BL-B01D1 seek to turn the tides of relapsed extensive-stage small cell lung cancer; although chemoimmunotherapy has earned its right as the frontline standard of care, both classes of agents have yet to demonstrate benefit in second or later lines.
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Perioperative Immunotherapy Improves EFS, But Clouds Optimal Sequencing in Early NSCLC
July 27th 2023Positive event-free survival data from the phase 3 AEGEAN, NEOTORCH, and KEYNOTE-671 trials add further evidence to the benefit of perioperative immunotherapy in early-stage non–small cell lung cancer but have yet to show clear biomarkers of response beyond PD-L1.
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FDA Clears Investigational New Drug Application for TCR-NK Cell Therapy in Multiple Myeloma
July 26th 2023The FDA has issued a ‘safe to proceed’ for the investigational new drug application enabling a phase 1 study evaluating NY-ESO-1 TCR/IL-15 NK, a first-in-class engineered T-cell receptor natural killer cell therapy for patients with relapsed/refractory multiple myeloma.
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Loncastuximab Tesirine BLA Receives Priority Review in China for Relapsed/Refractory DLBCL
July 24th 2023The China National Medical Products Administration has accepted and granted priority review to the biologics license application seeking the approval of loncastuximab tesirine-lpyl for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma following at least 2 prior lines of systemic therapy.
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CHMP Advises Against Adagrasib Approval for KRAS G12C–Mutant Advanced NSCLC
July 24th 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a negative opinion on the conditional marketing authorization application for adagrasib for the treatment of patients with KRAS G12C–mutated advanced non–small cell lung cancer.
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JZP458 Receives CHMP Recommendation for Approval in ALL, Lymphoblastic Lymphoma
July 21st 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of JZP458 for use in combination with multi-agent chemotherapy for the treatment of adult and pediatric patients 1 month and older with acute lymphoblastic leukemia and lymphoblastic lymphoma who developed hypersensitivity or silent inactivation to Escherichia coli–derived asparaginase.
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