Hayley Virgil is a senior editor with CancerNetwork. When she isn't traveling to conferences and championing health equity in the oncology space, she can be found hiking, foraging wild plants, gardening, sewing ballgowns, practicing embroidery, or playing video games.
Despite Trends Towards PFS, OS Improvement, Pembrolizumab/Lenvatinib Trial in HCC Misses Primary End PointsAugust 4th 2022
Although patients with unresectable hepatocellular carcinoma initially appeared to have survival benefit following treatment with pembrolizumab and lenvatinib vs lenvatinib alone, the findings did not meet statistical significance.
Intermittent Dosing Schedule for Zandelisib Appears Safe With Low Incidence of High-Grade AEs in R/R B-Cell MalignanciesJuly 30th 2022
Patients with relapsed/refractory B-cell malignancies who received zandelisib at 60 mg via an intermittent dosing schedule experienced a low incidence of grade 3 or higher adverse effects.
Neoadjuvant mFOLFIRINOX Alone Yields Favorable Survival in Borderline Resectable PDACJuly 28th 2022
Patients with borderline resectable pancreatic ductal adenocarcinoma experienced favorable overall survival following treatment with mFOLFIRINOX alone, with additional hypofractionated radiotherapy showing little benefit.
KRAS G12D+ NSCLC Demonstrates Unique Features, Worse Outcomes Following PD-L1 Agents Vs Other KRAS MutationsJuly 27th 2022
Distinct clinical, genomic, and immunologic features were observed among patients with KRAS G12D–positive non–small cell lung compared with those with other types of KRAS positivity.
EMA Gives Positive CHMP Opinion for Teclistamab Relapsed/Refractory Myeloma IndicationJuly 27th 2022
Patients with relapsed/refractory multiple myeloma appear to benefit from treatment with teclistamab, which was given a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use.
Full Marketing Authorization Granted to Selinexor Combo by European Commission for Pretreated Multiple MyelomaJuly 24th 2022
Patients in Europe who have multiple myeloma and have received at least 1 previous therapy can now receive treatment with selinexor plus bortezomib and low-dose dexamethasone following its full marketing authorization by the European Commission.
Pembrolizumab, CRT Combo Misses EFS End Point in Unresected Locally Advanced HNSCCJuly 22nd 2022
The phase 3 KEYNOTE-412 trial assessing pembrolizumab and consolidation chemoradiotherapy plus maintenance pembrolizumab in unresected locally advanced head and neck squamous cell carcinoma missed its primary end point of event-free survival improvement vs matched placebo.
Pre-HSCT WT1 Levels Vs ELN 2017 Risk Classification Is a Better Predictor of Outcomes in Intermediate-Risk AMLJuly 20th 2022
Although European Leukemia Net 2017 Risk Stratification was ineffective for predicting outcomes following allogeneic hematopoietic stem cell transplantation in intermediate-risk acute myeloid leukemia, pre-transplant Wilms tumor gene 1 expression and FLT3-ITD mutation demonstrated promising predictive ability.
Carfilzomib Appears Safe, Efficacious in Japanese Patients With Relapsed/Refractory Multiple MyelomaJuly 20th 2022
Post-marketing surveillance data further confirmed carfilzomib to be a well-tolerated and promising option among patients with relapsed/refractory multiple myeloma, although investigators emphasize the importance of watching for cardiac comorbidities.
Trastuzumab Deruxtecan Receives EU Approval for Previously Treated Unresectable/Metastatic HER2+ Breast CancerJuly 19th 2022
European patients with unresectable or metastatic HER2-positive breast cancer are now able to receive treatment with trastuzumab deruxtecan following 1 or more previous anti-HER2 regimens.
FOLFOX Plus Trastuzumab and Nivolumab Demonstrated Promising Efficacy in ERBB2+ Esophagogastric AdenocarcinomaJuly 19th 2022
Patients with ERBB2-positive esophagogastric adenocarcinoma appeared to experience improved efficacy following treatment with a combination of trastuzumab and nivolumab plus leucovorin, fluorouracil, and oxaliplatin vs historical data.
Long-Term Follow-Up Indicates Adjuvant Pertuzumab, Trastuzumab, and Chemo Reduces Recurrence in HER2+ Early Breast CancerJuly 18th 2022
Long-term follow-up data continue to show that patients with lymph node–positive, HER2-positive early breast cancer at a high risk of recurrence derived notable, durable benefit from treatment with adjuvant pertuzumab, trastuzumab, and chemotherapy.
FDA Lifts Clinical Hold on Phase 3 Trial Assessing GLSI-100 in Patients With HER2/Neu-Positive Breast Cancer and HLA-A*02July 15th 2022
The FDA has allowed the phase 3 FLAMINGO-01 trial assessing GLSI-100 in patients with HER2/Neu-positive breast cancer and HLA-A*02 positive to proceed following concerns related to the manufacturing and pharmacy process.
FDA Expresses Caution About Increased Risk of Death, Serious AEs Associated With Duvelisib in CLL/SLLJuly 11th 2022
The regulatory organization indicated that duvelisib induces increased risk of death or serious adverse effects in patients with chronic lymphocytic leukemia and small lymphocytic leukemia.
Toripalimab BLA Resubmission Accepted by FDA for the Treatment of Advanced Nasopharyngeal CarcinomaJuly 8th 2022
After receipt of a complete response letter in May 2022, a biologics license application for toripalimab monotherapy in the second line or later following platinum chemotherapy or in combination with chemotherapy in the first-line setting for advanced recurrent or metastatic nasopharyngeal carcinoma was resubmitted to and accepted by the FDA.
OS Not Improved, Modest PFS Benefit Noted Following Chemo Maintenance in Newly Diagnosed Advanced Ovarian CancerJuly 8th 2022
Patients with advanced newly diagnosed ovarian, tubal, or peritoneal cancer did not derive further survival benefit from maintenance chemotherapy, although a modest improvement in progression-free survival was observed compared with surveillance.
Supplemental New Drug Application Submitted in Japan for Trastuzumab Deruxtecan in HER2-Low Breast CancerJuly 5th 2022
Patients with HER2-low unresectable or recurrent breast cancer in Japan could receive treatment with trastuzumab deruxtecan in the future if the newly submitted supplemental new drug application for this indication is approved.
FDA Grants Breakthrough Therapy Designation to Talquetamab for Relapsed/Refractory Multiple MyelomaJuly 1st 2022
Patients with relapsed/refractory multiple myeloma who have received at least 4 prior lines of therapy might benefit from treatment with talquetamab, which was granted breakthrough therapy designation by the FDA.