Tim Cortese

An independent data monitoring committee suggested the submission of an early NDA for serplulimab plus chemotherapy in early-stage gastric cancer.

The 10-year biochemical DFS rate was 86% with EBRT plus focal boost vs 71% with standard EBRT in those with intermediate- and high-risk prostate cancer.

Data from a phase 1/1b trial showed that WTX-124 achieved clinically meaningful activity in those with advanced melanoma following SOC immunotherapy.

Findings from the phase 3 C-POST trial support the FDA approval of cemiplimab in this cutaneous squamous cell carcinoma population.

Patients with multiple myeloma who received palonosetron, dexamethasone, aprepitant, and olanzapine achieved a 44.1% CR rate across all study phases.

Casdatifan, administered at 100 mg once daily, achieved a confirmed ORR of 35% in patients with pretreated metastatic kidney cancer.

Those with limited-stage small cell lung cancer who had elevated ProGRP levels at baseline had worse OS and PFS outcomes vs those with normalized levels.

A real-world, retrospective analysis showed that CRS and ICANS occurred in 48% and 16% of patients with ES-SCLC who were treated with tarlatamab.

Combination therapy of ETX-636 plus fulvestrant is being administered to patients with HR–positive, HER2-negative breast cancer in a phase 1/2 trial.

D-VRd had a 72% chance of providing superior PFS outcomes vs isatuximab plus VRd in patients with transplant-ineligible NDMM.

A phase 1 trial is evaluating UB-VV111 with and without rapamycin as treatment for patients with CLL and LBCL who received at least 2 prior therapies.

SBRT achieved a 5-year DFS rate of 89% vs 92% with moderately hypofractionated IMRT in patients with intermediate-risk prostate cancer.

Adjuvanted imsapepimut and etimupepimut plus pembrolizumab did not yield a statistically significant PFS improvement as treatment for advanced melanoma.

The addition of 177Lu-PNT2002 did not significantly increase toxicity in patients with oligorecurrent prostate cancer who received SBRT.

Planned interim results from the phase 3 DESTINY-Breast05 trial showed no new safety signals with T-DXd in the trial population.

Physicians are no longer required to have special certification to administer vandetanib to patients with medullary thyroid cancer.

Atebimetinib with gemcitabine and nab-paclitaxel achieved 9-month OS and PFS of 86% and 53%, respectively, in patients with pancreatic cancer in frontline settings.

Results from the phase 3 DESTINY-Breast09 trial will support the FDA’s decision on whether to approve T-DXd plus pertuzumab in frontline metastatic breast cancer.

Results from the phase 2 MorningSun trial demonstrated that outpatient, subcutaneous single-agent mosunetuzumab was efficacious in patients with marginal zone lymphoma.

At 30 months, mitazalimab plus mFOLFIRINOX achieved an OS rate of 21% in patients with previously untreated metastatic PDAC.

Michael Wang, MD, stated that results from this phase 2 trial were tremendous and showed that mosunetuzumab plus polatuzumab vedotin is viable in MCL.

Patients with PDAC and non-GOF mutations had less favorable OS and DFS outcomes in various instances compared with those who had wild-type genes or GOF mutations.

The agency has recommended approval for subcutaneous pembrolizumab in all previous solid tumor indications, and for pembrolizumab in recurrent HNSCC.

Data from the phase 3 3475A-D77 trial support the FDA approval of subcutaneous pembrolizumab across different pediatric and adult solid tumor indications.

Patients with high-risk multiple myeloma who received BPd maintenance therapy reported no events of progression in the phase 2 trial.

MRD-negative remission was achieved in 74.8% of all patients with newly diagnosed multiple myeloma treated with isatuximab, carfilzomib, lenalidomide, and dexamethasone.

The next-generation ADC, CRB-701, demonstrated an emerging objective response rate of 57% in a subgroup of patients with HNSCC.

Cisplatin/etoposide and carboplatin/etoposide achieved median OS of 8.8 months and 7.8 months, respectively, in those with extensive-stage small cell lung cancer.

Data from a phase 1/2a trial showed that plixorafenib-based care achieved a median PFS of 63.9 months in patients with BRAF-altered thyroid cancers.

Findings from a phase 1 trial and the REJOICE-Ovarian01 trials supported the FDA’s decision to grant the designation to R-DXd in those with gynecologic cancers.