
Rui-Hua Xu, MD, PhD, and Kohei Shitara, MD, expand on the advantages of targeting CLDN18.2 with zolbetuximab in gastric/GEJ adenocarcinoma and key efficacy data from the GLOW and SPOTLIGHT trials in support of zolbetuximab’s potential FDA approval.

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Rui-Hua Xu, MD, PhD, and Kohei Shitara, MD, expand on the advantages of targeting CLDN18.2 with zolbetuximab in gastric/GEJ adenocarcinoma and key efficacy data from the GLOW and SPOTLIGHT trials in support of zolbetuximab’s potential FDA approval.

Paul G. Richardson, MD, shares clinical findings and several case studies showcasing the encouraging activity and safety of mezigdomide in patients with relapsed/refractory multiple myeloma.

The FDA has approved enfortumab vedotin in combination with pembrolizumab for patients with locally advanced or metastatic urothelial cancer.

Marijo Bilusic, MD, PhD, highlights key insights about renal cell carcinoma that were presented at the meeting covering considerations on sequencing TKIs, the need for further research to elucidate novel therapies, and the importance of offering clinical trials to all patients with genitourinary malignancies.

The combination of pembrolizumab and lenvatinib failed to produce a statistically significant improvement in progression-free survival and overall survival vs platinum-based chemotherapy with carboplatin and paclitaxel as frontline therapy in patients with advanced or recurrent endometrial cancer whose disease in mismatch repair proficient/not microsatellite instability–high or mismatch repair deficient.

The FDA has granted fast track designation to naporafenib plus trametinib for use as a potential therapeutic option in adult patients with unresectable or metastatic melanoma with an NRAS mutation who progressed on or are intolerant to a PD-1/PD-L1–based regimen.

Treatment with zanubrutinib conferred a PFS benefit vs bendamustine plus rituximab across most biomarker subgroups of patients with treatment-naive chronic lymphocytic leukemia or small lymphocytic lymphoma without del(17p), according to findings from the phase 3 SEQUOIA trial.

The FDA has approved belzutifan (Welireg) for the treatment of patients with advanced renal cell carcinoma (RCC) following a PD-1 or PD-L1 inhibitor and a VEGF TKI.

The majority of patients with relapsed CLL treated with zanubrutinib or ibrutinib in the phase 3 ALPINE study did not acquire a BTK or PLCG2 mutation at the time of disease progression, indicating that these mutations may not be the primary drivers of resistance and relapse in this population.

The combination of RP1 and cemiplimab provided a numerical, but not statistically significant, improvement in response rates vs cemiplimab alone in patients with locally advanced or metastatic cutaneous squamous cell carcinoma, missing the primary end points of the phase 2 CERPASS trial.

Idecabtagene vicleucel has received marketing and manufacturing approval in Japan for its supplemental new drug application in patients with relapsed/refractory multiple myeloma who have received at least 2 prior lines of therapy.

Jaime R. Merchán, MD, discusses the evolution and current role of IO/TKI regimens in advanced RCC; highlights data from the phase 3 CLEAR and KEYNOTE-426 trials supporting the use of pembrolizumab-based regimens in untreated ccRCC; and speculates on how future biomarker-driven research could improve the benefit seen with these combinations in this disease.

The FDA has accepted and granted priority review to the biologics license application seeking the approval of tarlatamab for the treatment of patients with advanced small cell lung cancer.

Press Release
Physician-scientists from Rutgers Cancer Institute of New Jersey and RWJBarnabas Health will present an extensive array of hematology/oncology data from their clinical research program at the 65th American Society of Hematology Annual Meeting and Exposition, being held in San Diego, California from December 9-12, 2023.

The novel bispecific antibody KN026 and docetaxel elicited responses with an acceptable toxicity profile when administered as neoadjuvant treatment in patients with HER2-positive early or locally advanced breast cancer.

The European Commission has granted marketing authorization to dostarlimab paired with carboplatin and paclitaxel in adults with dMMR/MSI-H primary advanced or recurrent endometrial cancer who are eligible to receive systemic treatment.

The FDA has approved eflornithine (Iwilfin) as a treatment to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma who have achieved at least a partial response to prior multi-agent, multimodality therapy including anti-GD2 immunotherapy.

Responses on the non-covalent BTK inhibitor pirtobrutinib remained high in patients with relapsed chronic lymphocytic leukemia who expressed frequent baseline BTK mutations, according to a genomic analysis of the phase 1/2 BRUIN trial.

Maria Hafez, MD, discusses factors such as HER2 status, lymph node negativity, and risk stratification that influence the selection of adjuvant treatment approaches for patients with early-stage HER2-positive breast cancer and expands on pivotal data that have changed the paradigm.

Press Release
University of California prostate cancer experts will share clinical insights at the first annual PSMA Conference, “PSMA PET and RLT: Present and Future.”

The presence of mutated SRSF2 in knock-in mouse models of JAK2 V617F–driven myeloproliferative neoplasms reduced the rate of polycythemia and hampered hematopoietic progenitor functions.

Javier Cortés, MD, PhD, expands on the importance of investigating the central nervous system activity of trastuzumab deruxtecan in patients with HER2-positive breast cancer and brain metastases; key efficacy data from the pooled analysis of the agent in the DESTINY-Breast01, -02 and -03 trials; and more.

DZD8586 showcased antitumor activity and favorable safety with limited grade 3 or greater treatment-emergent adverse effects in patients with heavily pretreated B-cell non-Hodgkin lymphoma, according to preliminary findings from a pooled analysis of two ongoing phase 1 trials.

Treatment with asciminib elicited greater efficacy and had a more tolerable safety profile compared with bosutinib for patients chronic myeloid leukemia in chronic phase following treatment with 2 or more TKIs.

The addition of isatuximab-irfc to carfilzomib, lenalidomide, and dexamethasone was well tolerated and elicited a 100% objective response rate in standard- and high-risk, transplant-eligible patients with newly diagnosed multiple myeloma.

Following promising preclincial findings, acimtamig plus allogenic natural killer cells will be examined for the treatment of patients with relapsed/refractory Hodgkin lymphoma and CD30-positive peripheral T-cell lymphoma.

Patients with high-risk large B-cell lymphoma experienced durable responses when treated with first-line axicabtagene ciloleucel, according to results from the phase 2 ZUMA-12 trial.

The use of tafasitamab-cxix, lenalidomide, rituximab, and acalabrutinib in the first-line setting induced high responses in patients with newly diagnosed diffuse large B-cell lymphoma, with responders deriving benefit from subsequent treatment with cyclophosphamide, doxorubicin, vincristine, and prednisolone.

Pirtobrutinib demonstrated promising efficacy and a tolerable safety profile in heavily pretreated patients with relapsed/refractory mantle cell lymphoma who received prior therapy with a covalent BTK inhibitor.

The novel BTK degrader BGB-16673 was well tolerated; produced meaningful and rapid clinical responses; and demonstrated on-target effects in patients with relapsed/refractory B-cell malignancies.