Jason M. Broderick

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.

Long-term data from the pivotal phase 3 ELARA trial showed durable efficacy with tisagenlecleucel in high-risk follicular lymphoma subgroups.

Maintenance teclistamab either alone or combined with lenalidomide was safe and induced high rates of MRD negativity in patients with newly diagnosed multiple myeloma.

Neoadjuvant pembrolizumab with chemotherapy led to greater pathologic regression based on percent residual volume tumor vs placebo plus chemotherapy in patients with early-stage non–small cell lung cancer.

The application is supported by results from the phase III DESTINY-Breast06 trial.