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
FDA Grants Orphan Drug Designation to Osemitamab for Pancreatic Cancer
April 10th 2023The FDA has granted an orphan drug designation to osemitamab for the treatment of patients with pancreatic cancer, marking the second ODD for the agent following its initial designation in 2021 for use in those with gastric and gastroesophageal junction cancer.
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FDA Accepts BLA for Trastuzumab Biosimilar in HER2+ Breast Cancer, Gastric/GEJ Cancer
April 5th 2023The FDA has accepted a biologics license application for the HLX02, a proposed trastuzumab biosimilar, as adjuvant therapy for patients with HER2-overexpressing breast cancer, HER2-overexpressing metastatic breast cancer, and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma
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FDA Accepts sNDAs for Encorafenib and Binimetinib in BRAF V600E–Mutant NSCLC
April 4th 2023The FDA has accepted for review supplemental new drug applications for the combination of encorafenib and binimetinib for the treatment of patients with metastatic non–small cell lung cancer harboring a BRAF V600E mutation, as detected by an FDA-approved test.
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The use of 4 cycles of chemotherapy plus durvalumab with or without tremelimumab-actl was associated with improved or sustained response and similar toxicity compared with chemotherapy alone as frontline therapy in patients with metastatic non–small cell lung cancer, according to post hoc exploratory findings from the phase 3 POSEIDON trial.
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Liso-cel Receives European Approval Recommendation for Relapsed/Refractory LBCL
March 31st 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of lisocabtagene maraleucel for the treatment of select patients with large B-cell lymphoma who relapsed within 12 months from completion of or developed refractory disease to frontline chemoimmunotherapy.
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Neoadjuvant Nivolumab Plus Chemotherapy Retains EFS Advantage in Resectable NSCLC
March 30th 2023Neoadjuvant nivolumab plus chemotherapy produced a long-term event-free survival benefit vs chemotherapy alone in patients with resectable non–small cell lung cancer, independent of whether patients underwent minimally invasive surgery or thoracotomy or complete or partial resection of the lung.
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European Commission Approves Cemiplimab Plus Chemotherapy for First-line PD-L1+ NSCLC
March 29th 2023The European Commission has approved cemiplimab-rwlc plus platinum-based chemotherapy for the frontline treatment of patients with locally advanced or metastatic PD-L1–positive non–small cell lung cancer without EGFR, ALK, or ROS1 alterations and who are not eligible for chemoradiation.
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Neoadjuvant Olaparib Proves Feasible, Aids Optimal Resection in BRCA-Mutant Ovarian Cancer
March 28th 2023Neoadjuvant treatment with olaparib prior to surgical resection and adjuvant chemotherapy was well tolerated and led to a 100% optimal resection rate in patients with newly diagnosed, BRCA-mutant ovarian, primary peritoneal, or fallopian tube cancer.
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Tolerability Hinders Adavosertib Activity in Recurrent or Persistent Uterine Serous Carcinoma
March 27th 2023Treatment with the oral, small-molecule Wee1 kinase inhibitor adavosertib was clinically active but not well tolerated in patients with recurrent or persistent uterine serous carcinoma who previously received platinum-based chemotherapy.
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FDA Issues Complete Response Letter for Ruxolitinib Extended-Release Tablets in MPNs
March 24th 2023The FDA has issued a complete response letter for ruxolitinib extended-release tablets for use once daily in the treatment of patients with certain types of myelofibrosis, polycythemia vera, and graft-vs-host disease.
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Acalabrutinib Receives Approval in China for Relapsed/Refractory Mantle Cell Lymphoma
March 23rd 2023Acalabrutinib has received conditional approval from the National Medical Products Administration in China for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
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MEDI9253 Plus Durvalumab Delivers Little Efficacy in Advanced/Metastatic Solid Tumors
March 22nd 2023The addition of MEDI9253 to sequential or concurrent treatment with durvalumab failed to elicit more than 1 partial response although proving feasible and safe in patients with advanced or metastatic solid tumors, according to findings from a phase 1 trial.
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FDA Grants Orphan Drug Designation to ISB 1442 for Relapsed/Refractory Multiple Myeloma
March 21st 2023The FDA has granted an orphan drug designation to ISB 1442, the first-in-class biparatopic 2+1 BEAT® bispecific antibody targeting CD38 and CD47 for the treatment of patients with relapsed/refractory multiple myeloma.
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The phase 1/2 trial evaluating the addition of Allocetra to standard chemotherapy administered via pressurized intraperitoneal aerosol chemotherapy received regulatory clearance to continue evaluation and launch the dose-escalation cohort in patients with advanced-stage peritoneal metastasis arising from solid tumors following the completion of an interim data review by an Independent Data and Safety Monitoring Board and the Israeli Ministry of Health.
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Enzalutamide Plus Leuprolide Improves MFS in Nonmetastatic Castration-Sensitive Prostate Cancer
March 17th 2023Enzalutamide plus leuprolide demonstrated a statistically significant and clinically meaningful improvement in metastasis-free survival compared with placebo plus leuprolide in patients with nonmetastatic castration-sensitive prostate cancer with a high-risk of biochemical recurrence.
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BPX-601 and BPX-603 Trials Discontinued in Advanced Solid Tumors
March 15th 2023Bellicum Pharmaceuticals has discontinued 2 phase 1/2 trials evaluating the safety and preliminary efficacy of the GoCAR T-cell products BPX-601 and BPX-603 in combination with rimiducid in heavily pretreated patients with advanced solid tumors following an assessment of the risk/benefit profile of the combination of BPX-601 and rimiducid.
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China ARCHES Study Meets Primary, Secondary End Points in Metastatic Prostate Cancer
March 14th 2023Enzalutamide plus androgen deprivation therapy produced a statistically significant improvement in time to prostate-specific antigen progression compared with ADT and placebo in men with metastatic hormone-sensitive prostate cancer, meeting the primary end point of the phase 3 China ARCHES study.
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Navigating Systemic Therapy for RCC: Balancing Risk Status and Response
March 13th 2023Despite a perhaps overwhelming number of combination regimens available for use in the frontline setting for patients with renal cell carcinoma, treatment decisions can still largely boil down to a patient’s risk status. For second-line therapy, investigators are looking to contemporary trials for guidance.
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China’s NMPA Accepts BLA for Enfortumab Vedotin in Locally Advanced/Metastatic Urothelial Cancer
March 10th 2023The Center for Drug Evaluation of the China National Medical Products Administration has accepted the biologics license application for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who received prior treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy.
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The FDA’s Oncologic Drugs Advisory Committee voted 11 to 2 that data from the phase 3 POLARIX trial support a favorable benefit-risk profile for polatuzumab vedotin-piiq in patients with previously untreated large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified.
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Treatment in HR+ Early Breast Cancer May be Best Guided by Risk of Recurrence
March 4th 2023After settling the debate of which patients with early-stage, hormone receptor–positive breast cancer require chemotherapy in addition to endocrine therapy, investigators have set their sights on determining whether ovarian function suppression can deliver the same effects of chemotherapy and when to recommend abemaciclib and olaparib.
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I-SPY 2 Framework Could Represent the Future of Drug Development in Breast Cancer
March 3rd 2023By moving away from adjuvant- to neoadjuvant-based protocols, such as I-SPY, investigators may be better able to develop effective treatments for patients in less time by refining the understanding of who will benefit from therapy, enabling strategies with multiple pathway targets, and testing approaches earlier in the disease course.
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Pembrolizumab Plus Standard Therapy Falls Short in mCRPC, EGFR-Mutant NSCLC Trials
February 28th 2023The addition of pembrolizumab to standard therapies failed to improve survival outcomes in patients with metastatic castration-resistant prostate cancer in the KEYNOTE-641 trial and patients with EGFR-mutated non–small cell lung cancer in the KEYNOTE-789 trial.
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Aileron Terminates Phase 1b Trial Evaluating ALRN-6924 in P53-mutant Breast Cancer
February 22nd 2023Despite treatment with the chemoprotective agent ALRN-6924, patients with p53-mutated breast cancer receiving neoadjuvant or adjuvant therapy with docetaxel, doxorubicin, and cyclophosphamide failed to meet the trial’s primary and secondary end points of duration and incidence of severe neutropenia in cycle 1 and incidence of chemotherapy-induced alopecia, respectively.
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Toripalimab Plus Chemotherapy Meets PFS End Point in PD-L1+ TNBC
February 21st 2023Toripalimab plus nab-paclitaxel demonstrated a significant improvement in progression-free survival compared with placebo and nab-paclitaxel in PD-L1–positive patients with stage IV or recurrent/metastatic triple-negative breast cancer.
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