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
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
Freshly Infused Zamtocabtagene Autoleucel Shows Encouraging Activity in Relapsed/Refractory DLBCL
February 16th 2023The dual CD19- and CD20-directed, freshly administered CAR T-cell therapy zamtocabtagene autoleucel elicited a high response rate with deepening responses over time in patients with relapsed/refractory diffuse large B-cell lymphoma.
Read More
Crovalimab Demonstrates Noninferiority to Eculizumab in Phase 3 COMMODORE 2 Trial in PNH
February 7th 2023Treatment with crovalimab led to disease control through transfusion avoidance and control of hemolysis in patients with paroxysmal nocturnal hemoglobinuria who have not been previously treated with complement inhibitors.
Read More
Rising Standards in Regulatory Decisions Highlight Challenges in Drug Development in Lung Cancer
February 6th 2023If the FDA’s Oncologic Drugs Advisory Committee meeting held on February 10, 2022, was any indication, the days of applying foreign single country or region data to support regulatory approval are gone; instead, regulatory decisions are headed toward the need for regional consistency through multiregional clinical trials, which could help the United States overcome the persistent underrepresentation of racial and ethnic minorities in drug development.
Read More