Jordyn Sava is an editor for Targeted Oncology.
SC Pembrolizumab Shows Noninferior PK in Metastatic NSCLC
Subcutaneous pembrolizumab demonstrated comparable efficacy vs intravenous administration in non–small cell lung cancer, with a significantly shorter injection time.
New Partnership Aims to Improve Lung Cancer Detection With AI
Amit Gupta, MD, discussed a new collaboration between University Hospitals Cleveland Medical Center and Qure.ai that aims to enhance early lung cancer detection.
FDA Oncology Actions: March 2025 Approvals and Designations
Here is a look back on all the FDA happenings from the month of March 2025.
FDA Clears IND Application for CER-1236 in Advanced Solid Tumors
A second phase 1 trial plans to evaluate CER-1236, a novel chimeric antigen receptor therapy, for solid tumors.
Neoadjuvant TAR-200 Plus Cetrelimab Safe in Cisplatin-Ineligible MIBC
Neal Shore, MD, FACS, discussed findings from the SunRISe-4 trial of TAR-200 and cetrelimab in muscle-invasive bladder cancer.
FDA Grants Breakthrough Therapy Designation to Darovasertib in Melanoma
A phase 3 trial plans to further assess neoadjuvant darovasertib for the potential treatment of patients with primary uveal melanoma.
Relacorilant Extends Survival in Platinum-Resistant Ovarian Cancer
The combination of relacorilant and nab-paclitaxel improved progression-free and overall survival in patients with platinum-resistant ovarian cancer.
Phase 1/2 Trial of TTX-MC138 Doses First Patient in Cohort 4
The fourth cohort of an ongoing phase 1/2 has dosed its first patient with TTX-MC138 in advanced solid tumors.
Ocular Events With Mirvetuximab Show No Impact on QoL in Ovarian Cancer
CAN-2409 Shows Strong OS Outcomes in ICI-Refractory NSCLC
Final phase 2a results showed that CAN-2409 led to a median overall survival of 24.5 months in immune checkpoint inhibitor–refractory patients with NSCLC.
FDA Grants Approval to Durvalumab in MIBC
This approval of durvalumab marks the first and only perioperative immunotherapy regimen available in muscle-invasive bladder cancer.
FDA Expands Indication for Lutetium-177 PSMA-617 in PSMA-Positive mCRPC
The FDA approved 177Lu PSMA-617 for prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer after androgen therapy.
Cema-Cel Advances CAR T Therapy for LBCL in ALPHA Trials
Frederick L. Locke, MD, discussed cema-cel's safety, efficacy, and potential for treating large B-cell lymphoma in earlier lines in the ALPHA trials.
BNT327 With Chemotherapy Elicits Strong Results in ES-SCLC
BNT327 combined with chemotherapy showed an overall response rate of 85.4% when used as a first-line treatment for extensive-stage small cell lung cancer.
Leronlimab Gets FDA Nod for Phase 2 Microsatellite-Stable CRC Trial
A phase 2 trial will evaluate leronlimab’s safety and efficacy for the treatment of patients with microsatellite stable metastatic colorectal cancer.
VXM01 Plus Avelumab Shows Safety, Tolerability in Recurrent Glioblastoma
Early results show that the combination of VXM01 plus avelumab demonstrated tolerable safety in recurrent glioblastoma.
MARIPOSA Confirms OS Benefit for Amivantamab/Lazertinib in EGFR+ NSCLC
Final overall survival data from the MARIPOSA trial show that amivantamab and lazertinib improves survival vs osimertinib in EGFR-mutated NSCLC.
Olvi-Vec Shows 71% Disease Control Rate in Platinum-Resistant ES-SCLC
Early trial results show combining the oncolytic virus olvi-vec with chemotherapy led to disease control and tolerable safety in extensive-stage small cell lung cancer.
FDA Backs Phase 3 Study of IMNN-001 in Advanced Ovarian Cancer
A phase 3 trial will evaluate IMNN-001, the first immunotherapy to show an overall survival benefit in ovarian cancer.
Bel-Sar Shows Promising Clinical and Immune Activity in NMIBC
Belzupacap sarotalocan showed rapid immune activation and a favorable safety profile as a treatment for non–muscle-invasive bladder cancer.
Nemvaleukin Alfa Development Halted in Ovarian Cancer
Nemvaleukin alfa with pembrolizumab missed the overall survival primary end point in ARTISTRY-7 for platinum-resistant ovarian cancer.
Tilsotolimod Combo Does Not Improve Outcomes in Refractory Melanoma
Tilsotolimod plus ipilimumab did not show benefit vs ipilimumab alone in anti–PD-1 refractory melanoma, despite prior positive phase 1/2 trial data.
FDA Grants Azer-Cel Fast Track Status in DLBCL
Azercabtagene zapreleucel has been granted fast track designation from the FDA for the treatment of diffuse large B-cell lymphoma.
FDA Clears IND Application for EVM14 Across Cancers
The FDA has cleared EVM14, making it the first mRNA therapeutic cancer vaccine for global clinical trials.
“Nutrition Is Crucial”: Enhancing Cancer Treatment and Survivorship Through Dietary Strategies
For Nutrition Awareness Month, we highlight the importance of tailoring dietary strategies to patients with cancer to improve outcomes and quality of life.
New AI Tool Predicts Prostate Cancer Treatment Success
A recent study suggests that using artificial intelligence to measure tumor size could reduce treatment failures by more than 70%.
Teclistamab, Daratumumab, Pomalidomide Is Feasible in Multiple Myeloma
Anita D'Souza, MD, discussed the results from the MajesTEC-2 and TRIMM-2 trials in patients with multiple myeloma.
FDA Grants Orphan Drug Designation to PEP-010 in Pancreatic Cancer
PEP-010 was granted FDA orphan drug designation for the treatment of pancreatic cancer.
FDA OKs TLX007-CDx in Prostate Cancer Treatment
TLX007-CDx is now an FDA-approved PSMA PET imaging agent in prostate cancer.
FDA Updates Decision on ProSense Cryoablation for Early-Stage Breast Cancer
The FDA has extended its review of the ProSense cryoablation system for early-stage breast cancer, with a decision expected after the first quarter of 2025.