Jordyn Sava is an assistant editor for Targeted Oncology.
CheckMate-8HW Meets Primary End Points With Nivolumab/Ipilimumab in mCRC
A dual primary end point of progression-free survival in the phase 3 CheckMate-8HW trial evaluating nivolumab and ipilimumab in metastatic colorectal cancer has been met.
FDA Grants 2 Designations to Cretostimogene Grenadenorepvec in NMIBC
The FDA has granted 2 designations to cretostimogene grenadenorepvec, an oncolytic immunotherapy, for the treatment of a specific type of high-risk bladder cancer:
Targeted Therapies Continue to Push the Field of EGFRm Lung Cancer Forward
In an interview with Targeted Oncology, Edward B. Garon, MD, MS, discussed the ever-changing treatment landscape for EGFR-mutated lung cancer, as well as the unmet needs and potential next steps for research in this space.
KVA12123 Appears Well-Tolerated in Advanced Solid Tumors Across 3 Doses
In the first 3 cleared monotherapy cohorts of the VISTA-101 trial, KVA12123 showed promising safety and pharmacokinetics with a sign of efficacy across patients with advanced solid tumors.
Inavolisib Combo Meets Primary End Point in PIK3CA-Mutated Breast Cancer
An experimental drug combination of inavolisib, palbociclib, and fulvestrant significantly improved progression-free survival in patients with HR-positive/HER2-negative PIK3CA-mutated breast cancer.
FDA Clears IND for CT071 in RRMM and Primary Plasma Cell Leukemia
CT071, a chimeric antigen receptor T-cell therapy candidate, had an investigational new drug application cleared by the FDA for patients with relapsed/refractory multiple myeloma and primary plasma cell leukemia.
FDA Receives IND for GTB-3650 in CD33+ AML and MDS
A phase 1 trial plans to be initiated in 2024 to investigate GTB-3650 for the treatment of patients with CD33-positive leukemia.
PSA Undetectable in First Patient With mCRPC Given Cu-67 SAR-bisPSMA
A patient with prostate cancer in the SECuRE trial treated with 2 cycles of 67Cu-SAR-bisPSMA at the 8GBq dose level has achieved undetectable prostate specific antigen levels.
Apalutamide Drives Ultra-Low PSA Levels in mCSPC
In an interview with Targeted Oncology, Neeraj Agarwal, MD, discussed findings from the TITAN trial which were presented at ESMO 2023.
A Look Back at the FDA News From November 2023
Here is a look back at the FDA happenings from the month of November 2023.
Timing of DLBCL Relapse Linked With Evolutionary Patterns
A report suggests the cause behind different outcomes among patients with diffuse large B-cell lymphoma who relapse, highlighting that patients whose cancer relapses shortly after treatment tend to have worse responses to additional chemotherapy-based treatment.
FDA Grants Priority Review to Enfortumab Vedotin/Pembrolizumab in mUC
Positive data from the phase 3 EV-302 trial of enfortumab vedotin with pembrolizumab in locally advanced or metastatic urothelial cancer have shifted the landscape.
Navigating the Landscape of Immunotherapy Toxicities
Matthew Hadfield, DO, discusses his passion for early-stage clinical trials and the need for more research into immunotherapy toxicities during the third episode of Emerging Experts.
Addressing Barriers to Care in the Community Oncology Setting
More work is needed in the community oncology setting to improve barriers to care and enrollment in clinical trials which are often due to geographic location, awareness, and eligibility criteria.
ACVR1 Inhibition With Pacritinib Leads to Anemia Improvement in MF
Based on in vitro data, pacritinib led to a 4-fold higher potency for inhibition of the hepcidin regulator ACVR1 vs momelotinib among patients with cytopenic myelofibrosis and led to an increase in red blood cell transfusion independence.
Telisotuzumab Vedotin Elicits Compelling Data in EGFR-Mutant, c-Met NSCLC
Telisotuzumab vedotin demonstrated promising efficacy and safety in patients with advanced nonsquamous non–small cell lung cancer with high or intermediate c-Met expression.
FDA Clears IND for CT-0525 in Solid Tumors Overexpressing HER2
CT-0525 is an ex vivo gene-modified autologous CAR-monocyte cellular therapy being evaluated for the treatment of HER2-overexpressing solid tumors.
CTLA4 Deletion Boosts CAR T-Cell Efficacy
The potential of CTLA4 deletion as a strategy to improve chimeric antigen receptor T-cell efficacy was observed in a study published in Immunity.
Zotatifin Triplet Gains FDA Fast Track Status in ER+/HER2- Breast Cancer
A fast track designation has been granted to zotatifin with fulvestrant, and abemaciclib for adult patients with estrogen receptor-positive/HER2-negative advanced or metastatic breast cancer.
FDA Approves Nirogacestat for Patients With Desmoid Tumors
Nirogacestat is now an FDA-approved option for adult patients with progressing desmoid tumors who require systemic treatment.
BLA Seeks Approval of Obe-Cel in B-ALL From the FDA
The biologics license application seeking the approval of obe-cel as a potential therapeutic option in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia has been submitted to the FDA.
Need for Systemic Therapy Remains in Sarcoma
In an interview with Targeted Oncology, Lisa B. Ercolano, MD, discussed the evolving treatment landscape for sarcomas and underscored the pivotal role of molecular profiling, while addressing the need for more efficacious systemic therapies.
FDA Clears IND for Phase 1B Study of TCB008 in AML
An investigational new drug application for TCB008 has been cleared by the FDA. A phase 1B trial will now assess the agent in patients with relapsed/refractory acute myeloid leukemia.
Context of Gender May Influence Fears Related to Low-Risk PTC
FDA Oks FoundationOne®CDx for Capivasertib/Fulvestrant in Breast Cancer
In addition to the approval of capivasertib and fulvestrant, the FDA has granted approval to the FoundationOne® CDx as a companion diagnostic to identify patients with advanced HR-positive, HER2-negative advanced breast cancer.
Venetoclax/Umbralisib/Ublituximab Combo Yields High uMRD Rates in CLL
The rate of undetectable minimal residual disease at 10-4 in bone marrow was 77%, including a 71% rate among 14 patients with chronic lymphocytic leukemia refractory to prior Bruton tyrosine kinase inhibitors treated with venetoclax, umbralisib, and ublituximab.
VBI-1901 Demonstrates Encouraging Clinical Activity in Recurrent GBM
VBI-1901 10µg plus GM-CSF had a disease control rate of 44% among 16 patients with recurrent glioblastoma in a phase 1/2a study.
MANIFEST-2 Meets Primary End Point With Pelabresib Plus Ruxolitinib in MF
Along with improvements shown for the primary and secondary end points of the phase 3 MANIFEST-2 trial in JAK inhibitor-naive patients with myelofibrosis, pelabresib plus ruxolitinib did not display any new safety signals.
BRUIN MCL-321 Trial Evaluates Pirtobrutinb Monotherapy in MCL
In an interview with Targeted Oncology, Michael Wang, MD, discussed the rationale of the phase 3 study and how positive results from this trial may further shape the mantle cell lymphoma treatment landscape.
FDA to Review sBLA for Amivantamab Plus Chemo in EGFRm Advanced NSCLC
Positive findings from the MARIPOSA-2 study of amivantamab with chemotherapy with or without lazertinib in locally advanced or metastatic non–small cell lung cancer with EGFR mutations support the submission of a supplemental biologics license application to the FDA.
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