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
FDA Accepts BLA Resubmission for Toripalimab in Advanced Nasopharyngeal Carcinoma
July 6th 2022The FDA has accepted for review a biologics license application resubmission for toripalimab both in combination and as monotherapy for patients with advanced recurrent or metastatic nasopharyngeal carcinoma, according to an announcement from drug developer Coherus.
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FDA Grants Priority Review to Mosunetuzumab for Relapsed/Refractory Follicular Lymphoma
July 6th 2022The FDA has accepted a biologics license application and granted a priority review designation to mosunetuzumab, a potential first-in-class CD20 and CD3 T-cell engaging bispecific antibody, for the treatment of patients with relapsed/refractory follicular lymphoma following at least 2 prior systemic therapies.
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ALRN-6924 Halts Development in P53-Mutant NSCLC, Advances in P53-Mutant Breast Cancer
July 1st 2022Drug manufacturer Aileron plans to stop further enrollment into a phase 1b trial (NCT04022876) after the chemoprotective agent ALRN-6924 missed its composite primary end point for patients with advanced p53-mutant non–small cell lung cancer.
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Durvalumab Plus Chemotherapy Improves pCR in Resectable NSCLC
June 30th 2022Neoadjuvant treatment with durvalumab plus platinum-based chemotherapy led to a statistically significant improvement in pathologic complete response and major pathologic response compared with chemotherapy alone in patients with resectable non–small cell lung cancer, according to findings from a planned interim analysis of the phase 3 AEGEAN trial.
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Durvalumab Plus Chemotherapy Maintains OS Benefit in Advanced Biliary Tract Cancer
June 30th 2022The addition of durvalumab to gemcitabine and cisplatin demonstrated an improvement in overall survival vs gemcitabine and cisplatin plus placebo as frontline therapy in patients with advanced biliary tract cancer, regardless of primary tumor location.
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HER-Vaxx Plus Chemotherapy Improves OS in HER2+ Advanced Gastric/GEJ Cancer
June 28th 2022The addition of the HER2-Vaxx vaccine to standard-of-care chemotherapy led to a significant improvement in overall survival vs SOC chemotherapy alone in patients with HER2-neu overexpressing advanced and metastatic gastric and gastroesophageal junction cancer.
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Olaparib Approaches EU Approval for BRCA+, High-Risk Early Breast Cancer
June 27th 2022The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of olaparib for the adjuvant treatment of patients with germline BRCA-mutated, HER2-negative, high-risk, early breast cancer who have received neoadjuvant or adjuvant chemotherapy.
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FDA Approves Liso-cel for Second-Line Relapsed/Refractory LBCL
June 24th 2022The FDA has approved lisocabtagene maraleucel as second-line therapy for adult patients with large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.
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Asciminib Moves Toward EU Approval for Ph+ CML in Chronic Phase
June 24th 2022The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended granting marketing authorization for asciminib for the treatment of adult patients with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase who were previously treated with at least 2 TKIs.
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Cobolimab Plus Dostarlimab Achieves Clinical Responses in Advanced Melanoma
June 24th 2022Treatment with the combination of cobolimab and dostarlimab led to an overall objective response rate and immune-related ORR of 42.9% consisting of all partial responses in patients with advanced or metastatic melanoma.
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HPN328 Elicits Antitumor Activity in Small Cell Lung Cancer and Other NETs
June 23rd 2022HPN328, a novel half-life extended DLL3-targeting T-cell engager, demonstrated clinical activity and tolerability in patients with pretreated small cell lung cancer and other neuroendocrine tumors, according to findings from a phase 1/2 study (NCT04471727).
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UK’s MHRA Accepts Marketing Authorization Application for Aumolertinib in EGFR+ NSCLC
June 22nd 2022The United Kingdom’s Medicines and Healthcare Products Regulatory Agency accepted for review the marketing authorization application for aumolertinib for the first-line treatment of adult patients with locally advanced or metastatic non–small cell lung cancer with activating EGFR mutations and locally advanced/metastatic EGFR T790M mutation–positive non–small cell lung cancer.
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Capmatinib Approved in Europe for METex14-Altered Advanced NSCLC
June 22nd 2022The European Commission has approved capmatinib as a single agent for the treatment of patients with MET exon14 skipping–altered advanced non–small cell lung cancer who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
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FDA Grants Orphan Drug Designation to Paxalisib for Atypical Rhabdoid, Teratoid Tumors
June 20th 2022The FDA has granted an orphan drug designation to paxalisib for use as a potential therapeutic option for patients with atypical rhabdoid and teratoid tumors, a rare and highly aggressive pediatric brain cancer.
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European Medicines Agency Validates Type II Variation Application for Liso-cel in Second-line LBCL
June 20th 2022The European Medicines Agency has verified its type II variation application to extend the indication for lisocabtagene maraleucel to include the treatment of adult patients with diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma, who are refractory or have relapsed within 12 months of initial therapy and are candidates for hematopoietic stem cell transplant.
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T-VEC Plus Pembrolizumab Generates Promising Responses, Safety in PD-1–Refractory Advanced Melanoma
June 20th 2022Adding talimogene laherparepvec to pembrolizumab led to encouraging responses with a manageable safety profile in patients with advanced melanoma who progressed on prior anti–PD-1 therapy, most notably in the adjuvant setting, according to findings from the phase 2 MASTERKEY-115 trial.
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Duvelisib and Oral Azacitidine Under Study With CHO(E)P in Peripheral T-Cell Lymphoma
June 15th 2022Duvelisib and oral azacitidine are each being studied in combination with CHOP/CHOEP chemotherapy in patients with previously untreated CD30-negative peripheral T-cell lymphoma in the randomized phase 2 Alliance A059102 trial.
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REGN5458 Elicits Early, Sustainable Responses in Heavily Pretreated Multiple Myeloma
June 13th 2022The bispecific antibody REGN5458 elicited rapid responses that were further characterized by their depth, durability, and low incidence of cytokine release syndrome in patients with relapsed/refractory multiple myeloma.
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Talquetamab Plus Daratumumab Generates High Response Rate in CD38-Refractory Myeloma
June 12th 2022The combination of talquetamab and daratumumab led to early onset and durable responses that deepened over time in patients with heavily pretreated multiple myeloma, most of whom were anti-CD38 refractory, according to findings from the phase 1b TRIMM-2 study.
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Decitabine Displays Comparable Outcomes, Improved Safety to Induction Chemotherapy in Older AML
June 11th 2022Decitabine demonstrated a comparable overall survival and rate of hematopoietic stem cell transplant in addition to a lower incidence of adverse effects vs induction chemotherapy with daunorubicin and cytarabine in older patients at least 60 years of age with acute myeloid leukemia.
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Sintilimab Plus Decitabine Demonstrates 62% ORR in Untreated, Higher-Risk MDS
June 10th 2022The combination of the PD-1 antibody sintilimab and decitabine elicited potent clinical activity and manageable safety with no grade 4 or 5 treatment-related adverse effects as frontline therapy in patients with higher-risk myelodysplastic syndrome, according to preliminary results from a phase 2 trial.
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FOLFOXIRI plus bevacizumab led to a significant improvement in progression-free survival, objective response rate, and R0/1 resections vs FOLFOX/FOLFIRI plus bevacizumab but resulted in increased toxicity in patients with initially unresectable colorectal cancer liver metastases and right-sided and/or RAS- or BRAF V600E–mutated primary tumors.
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Gastrointestinal Cancers Recap at ASCO 2022: Dr Tanios Bekaii-Saab
June 6th 2022OncLive® will be LIVE with OncLive® News Network: On Location at the 2022 ASCO Annual Meeting. Each day, we will broadcast a series of interviews with top thought leaders, to learn their thoughts and reactions to data presented across oncology during the conference.
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RVd Plus Transplant and Lenalidomide Maintenance Improves PFS in Newly Diagnosed Myeloma
June 5th 2022The combination of lenalidomide (Revlimid), bortezomib, and dexamethasone (RVd) plus autologous stem cell transplant as initial therapy followed by lenalidomide maintenance demonstrated a significant improvement in progression-free survival vs RVd alone followed by lenalidomide maintenance in patients with newly diagnosed multiple myeloma.
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Preview of ASCO 2022: Dr Everett Vokes
June 5th 2022OncLive® will be LIVE with OncLive® News Network: On Location at the 2022 ASCO Annual Meeting. Each day, we will broadcast a series of interviews with top thought leaders, to learn their thoughts and reactions to data presented across oncology during the conference.
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SOT101 Displays Antitumor Activity Alone and With Pembrolizumab in Advanced Solid Tumors
June 4th 2022SOT101 alone and in combination with pembrolizumab demonstrated a favorable safety profile with no additional toxicities reported and promising efficacy among patients with advanced solid tumors, according to findings from the phase 1 AURELIO-03 trial.
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