Jason M. Broderick

The FDA has cleared investigational new drug applications for ZW251 and RV‑01, advancing novel treatments for solid tumors in first-in-human trials.

The CDK2 inhibitor INCB123667 showed positive efficacy and safety signals in platinum-resistant/refractory ovarian cancer.

New research suggests that certain patients with low-risk thyroid cancer can safely forgo postoperative radioiodine ablation without compromising long-term outcomes.

A study reveals that venetoclax consolidation after BTKi therapy is effective for chronic lymphocytic leukemia, offering promising outcomes for patients.

Despite major advances, real-world data show diminishing survival outcomes and treatment-limiting toxicities in second line or later CLL treatment.

The survival benefit with cadonilimab in cervical cancer in the overall phase 3 COMPASSION-16 study population was sustained across prespecified subgroups.

DZD8586 achieved a high response rate in patients with relapsed/refractory CLL/SLL.

Radium-223 in mCRPC showed long-term favorable safety, low second primary malignancies/fracture rates, and consistent overall survival.

Patritumab deruxtecan did not improve overall survival compared to chemotherapy in EGFR-mutated NSCLC, despite showing PFS and ORR benefits previously.

The next-generation KRAS G12C inhibitor MK-1084 showed promising efficacy and safety as a single agent and in combinations for advanced colorectal cancer.

Anlotinib plus chemotherapy has emerged as a first-line alternative to bevacizumab/chemotherapy in RAS/BRAF wild-type metastatic colorectal cancer.

Invikafusp alfa elicited clinically meaningful antitumor activity in patients with advanced solid tumors resistant to anti–PD-1/PD-L1 agents.

A retrospective analysis showed higher response rate for cabozantinib/nivolumab vs. lenvatinib/pembrolizumab in advanced RCC, with no significant survival or safety differences.

Combining the antibody-drug conjugate disitamab vedotin with BCG elicited a high complete response rate in patients with HER2-expressing, high-risk NMIBC.

The gene therapy nadofaragene firadenovec demonstrated strong clinical activity in Japanese patients with BCG-unresponsive non–muscle-invasive bladder cancer.

Melphalan flufenamide (melflufen) is approved in Europe for relapsed/refractory multiple myeloma, but the FDA withdrew its approval of the treatment last year.

Nivolumab plus ipilimumab showed a strong median overall survival (OS) advantage at 12 months and a trend toward overall prolonged OS vs SOC in non-clear cell renal cell carcinoma.

Neoadjuvant nivolumab/chemotherapy followed by response-stratified de-escalated chemoradiation showed strong potential in HPV-negative head and neck cancer.

The FDA is evaluating a new drug application for taletrectinib in patients with ROS1 fusion–positive non–small cell lung cancer.

Vepdegestrant extended PFS vs fulvestrant in patients with ESR1m+, ER+/HER2– breast cancer who progressed on CDK 4/6 inhibitors and endocrine therapy.

The antibody-drug conjugate FOR46 showed the strong potential of using CD46 as a new therapeutic target in metastatic castration-resistant prostate cancer.

The TKI zongertinib is currently being reviewed by the FDA for a potential approval for patients with HER2 mutation–positive non–small cell lung cancer.

Mutant KRAS in ctDNA in patients with localized pancreatic cancer was shown to be a biomarker for metastatic progression and overall survival.

The anti–PD-1/VEGF combination of pembrolizumab and bevacizumab elicited strong clinical activity in patients with melanoma brain metastases.

The off-the-shelf chimeric antigen receptor T-cell therapy P-BCMA-ALLO1 was shown to be safe and elicited strong anti-tumor activity in patients with relapsed/refractory multiple myeloma.

The addition of 177Lu-PSMA-617 to enzalutamide significantly improved overall survival and QOL in patients with metastatic castration-resistant prostate cancer.

5-year follow-up results from the phase 3 CheckMate 649 trial showed sustained efficacy with frontline nivolumab plus chemotherapy vs chemotherapy alone in patients with gastric cancers.

A regimen using the PD-L1 inhibitor atezolizumab in the neoadjuvant and adjuvant settings did not improve outcomes in patients with triple-negative breast cancer.

Adjuvant olaparib continued to show a strong efficacy benefit in patients with BRCA1/2 mutation–positive, HER2-negative high-risk breast cancer, according to 6-year data from the OlympiA trial.

“These long-term data support axicabtagene ciloleucel as a highly effective therapeutic approach for patients with relapsed or refractory indolent non-Hodgkin lymphoma, with curative potential in patients with follicular lymphoma,” said Sattva S. Neelapu, MD.