New Companion Diagnostic Is Approved to Aid In Gastric Cancer Decision Making
The PD-L1 IHC 22C3 pharmDx diagnostic tool will help identify patients with gastric or gastroesophageal junction adenocarcinoma whose disease expresses PD-L1 and who are thereby eligible for pembrolizumab.
Phase 3 KEYNOTE-564 Meets it Secondary Endpoint in RCC
Adjuvant pembrolizumab improved overall survival vs placebo in patients with renal cell carcinoma at intermediate-high or high risk of recurrence.
Induction Chemotherapy Improves Chemoradiation Success in Locally Advanced Cervical Cancer
Patients who received induction chemotherapy prior to chemoradiation had a 35% reduced risk of progression or death.
FoundationOne CDx/FoundationOne Liquid CDx Are Approved as Companion Diagnostics for Encorafenib/Binimetinib
The FDA has approved tests to identify patients with metastatic non–small cell lung cancer who are eligible for treatment with encorafenib plus binimetinib.
FoundationOne CDx Is Approved to Help Identify Patients Who Are Eligible for Selpercatinib
The approval of FoundationOne CDx as a companion diagnostic for selpercatinib seeks to broaden access to therapies for patients with RET fusion–positive solid tumors.
FDA Launches Priority Review of Belzutifan for Previously Treated Advanced RCC
The FDA has granted belzutifan priority review designation based on data from the phase 3 LITESPARK-005 trial.
Mezigdomide Plus Dexamethasone Generates Encouraging Responses in R/R Myeloma
Patients with heavily pretreated relapsed/refractory multiple myeloma, including those with lenalidomide and pomalidomide-refractory disease, showed encouraging responses with mezigdomide plus dexamethasone.
Ivosidenib NDA Receives Priority Review Designation for IDH1+ Relapsed/Refractory MDS
The FDA has granted ivosidenib priority review designation based on data from a phase 1 trial.
Camsirubicin Leads to Tumor Size Reduction in 2 Patients With Advanced Soft Tissue Sarcoma
Two patients experienced 18% and 20% reductions in tumor size following treatment with camsirubicin.
Gilead Discontinues Phase 3 ENHANCE Trial in Higher-Risk MDS
The first-line combination of magrolimab and azacitidine will no longer be investigated in patients with higher-risk myelodysplastic syndrome.
Phase 3 Findings Show PFS Benefit With Frontline Rivoceranib Plus Camrelizumab in Patients With Unresectable HCC
Patients with unresectable hepatocellular carcinoma who received rivoceranib/camrelizumab achieved a median progression-free survival of 5.6 months vs 3.7 months with sorafenib.
Selinexor Maintenance Demonstrates Efficacy in TP53 Wild-Type Advanced Endometrial Cancer Following Frontline Chemotherapy
Patients with TP53 wild-type endometrial cancer experienced a median progression-free survival of 27.4 months vs 5.2 months with placebo.
ASP-1929 Plus Pembrolizumab Generates Clinical Activity in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
ASP-1929, an antibody-dye conjugate, plus pembrolizumab, induced a 29.4% overall response rate in patients with recurrent or metastatic head and neck squamous cell carcinoma.
Nivolumab-Based Chemoimmunotherapy Sparks PFS, OS Improvements in Urothelial Carcinoma
The phase 3 CheckMate-901 trial met its dual primary end points for progression-free survival and overall survival.
Quizartinib Plus Chemo Gains FDA Approval for Newly Diagnosed, FLT3-ITD+ AML
Quizartinib has been approved by the FDA for use with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy after consolidation chemotherapy, to treat adults with newly diagnosed acute myeloid leukemia that is FLT3-ITD positive, as detected by an FDA-approved test.
Dose-Dense and Dose-Intense ABVD Is Linked To Improved PFS in Frontline Treatment of Advanced Classical Hodgkin Lymphoma
Intensified doxorubicin, bleomycin, vinblastine, dacarbazine, and granulocyte colony–stimulating factor (ABVD) was associated with a 56% reduction in the relative risk of 3-year progression, relapse, or death.
Intra-Arterial Gemcitabine Linked to OS Improvement Vs IV Gemcitabine/Nab-Paclitaxel in Locally Advanced Pancreatic Cancer
The median overall survival with intra-arterial gemcitabine was 15.7 months vs 10.1 months with intravenous gemcitabine and nab-paclitaxel.
MB-106 Elicits Antitumor Activity in BTK Inhibitor–Refractory Waldenström Macroglobulinemia
Patients with Waldenström macroglobulinemia who were refractory to a BTK inhibitor achieved preliminary responses with the CD20-targeted CAR T-cell therapy MB-106.
Lifileucel Under Priority Review For Advanced Melanoma
The FDA has launched a priority review of lifileucel based on data from the phase 2 C-144-01 trial.
Mitazalimab and Modified FOLFIRINOX Garners Responses in Metastatic PDAC Phase 2 Trial
Mitazalimab and modified FOLFIRINOX produced a 57% objective response rate among patients with metastatic pancreatic ductal adenocarcinoma in the frontline setting.
Elranatamab Induces Responses in Patients With Relapsed/Refractory Multiple Myeloma Following BCMA-Directed Therapy
Patients with relapsed/refractory multiple myeloma treated with elranatamab following any prior BCMA-directed therapy achieved an overall response rate of 46%.
Cilta-cel Showcases PFS Improvement Following First Relapse In Lenalidomide-Refractory Myeloma
Ciltacabtagene autoleucel improved progression-free survival vs pomalidomide, bortezomib, and dexamethasone or daratumumab, pomalidomide, and dexamethasone in patients with lenalidomide-refractory multiple myeloma.
Pembrolizumab, In Addition To Chemotherapy, Misses Mark in TKI-Resistant, EGFR+ NSCLC
Numerical, but not statistically significant, improvements in survival were observed in patients with TKI-resistant, EGFR-mutated, metastatic nonsquamous non–small cell lung cancer who received pembrolizumab to pemetrexed and platinum-based chemotherapy.
Adjuvant Osimertinib Translates Meaningful OS Benefit in EGFR+ Stage IB-IIIA NSCLC
Adjuvant osimertinib reduced the risk of death by 51% compared with placebo for patients with EGFR-mutated, stage IB, II, or IIIA non–small cell lung cancer.
Final OS Analysis Confirms Benefit of Pembrolizumab/Chemotherapy With or Without Bevacizumab in Frontline Cervical Cancer
Updated findings from KEYNOTE-826 support the use of pembrolizumab plus chemotherapy with or without bevacizumab for select patients with cervical cancer.
Pembrolizumab Plus Lenvatinib Gains NICE Recommendation for Previously Treated Advanced or Recurrent Endometrial Cancer
The United Kingdom’s National Institute for Health and Care Excellence has updated their guidelines to recommend pembrolizumab plus lenvatinib for patients with previously treated endometrial cancer.
FDA Delivers Complete Response Letter for Trastuzumab Duocarmazine in Advanced HER2+ Breast Cancer
The FDA has issued a complete response letter for vic-trastuzumab duocarmazine.
VB10.16 Plus Atezolizumab Provides 25-Month Median OS to Patients with PD-L1+ Advanced Cervical Cancer
Patients with PD-L1–positive, human papillomavirus 16–positive advanced, cervical cancer derived a median overall survival greater than 25 months with VB10.16/atezolizumab.
FDA Delays Quizartinib PDUFA Date for Newly Diagnosed FLT3-ITD+ AML
The FDA has pushed back the PDUFA date for quizartinib for select patients with acute myeloid leukemia.
Intermittent Dosing Strategy Helps Thrombocytopenia Related to MDM2 Inhibitor Milademetan
Milademetan, a MDM2 inhibitor, is associated with thrombocytopenia. An intermittent dosing schedule may help mitigate that adverse event.
Endocrine Therapy Plus Ovarian Suppression Remains An Effective Treatment Strategy in HR+, HER2-, Early Breast Cancer
Investigators Present Real-World Experiences With T-DXd Following HER2 Status Changes
Maintenance Pembrolizumab/Olaparib Falls Short in Locally Advanced, Metastatic TNBC
Neoadjuvant Pembrolizumab Improves pCR Across ER+ Breast Cancer Subgroups
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