Sabrina Serani

Data from the phase 3 INAVO120 trial support the priority review granted by the FDA to inavolisib, palbociclib, and fulvestrant for the treatment of PIK3CA-mutated breast cancer.

In part 2 of our 3-part series, antibody-drug conjugates like enfortumab vedotin and tisotumab vedotin offer novel options for difficult-to-treat tumors.

The FDA has set a target action date of September 27, 2024, for a decision on the supplemental biologics license application of isatuximab plus bortezomib, lenalidomide, and dexamethasone.

In part 1 of our 3-part series, antibody-drug conjugates are revolutionizing oncology, targeting cancer cells precisely. Agents like T-DM1, T-DXd, and sacituzumab govitecan continue to change the field.

An interim analysis of the CheckMate 77T trial shows that nivolumab plus chemotherapy improves event-free survival in resectable non-small cell lung cancer vs chemotherapy alone.

Valentina Ardila, MD, encouraged further research to understand the complex interplay between obesity, immune response, and transplant outcomes.

Data from the phase 3 INAVO120 trial support the breakthrough therapy designation granted by the FDA to inavolisib, palbociclib, and fulvestrant for the treatment of PIK3CA-mutated breast cancer.

Jose Lutzky, MD, discussed the promise of tumor infiltrating lymphocyte therapy for difficult-to-treat advanced melanoma.

The FDA has given the novel agent NVL-655 a breakthrough therapy designation for the treatment of patients with ALK-positive locally advanced or metastatic non-small cell lung cancer.

The FDA accelerated approval of tarlatamab makes it the first bispecific T-cell engager therapy for a major solid tumor.

For Melanoma and Skin Cancer Awareness Month, Nayoung Lee, MD, discussed evolving paradigms in skin cancer diagnosis and prevention.

The phase 3 KeyVibe-010 study will discontinue the coformulation of pembrolizumab and vibostolimab treatment for high-risk melanoma due to futility.

Nivolumab with ipilimumab did not lead to progression-free survival benefits in patients with unresectable stage III non-small cell lung cancer, missing the primary end point of the CheckMate -73L study.

If approved, this would mark the first Epstein-Barr virus-related mRNA therapeutic cancer vaccine.

Compared with ruxolitinib, momelotinib improved mild, moderate, and severe anemia in patients with myelofibrosis who were naive to JAK inhibitors, according to the phase 3 SIMPLIFY-1 study.

The phase 3 KEYNOTE-B21 study missed its primary end point, as pembrolizumab plus chemotherapy did not improve disease-free survival in newly diagnosed, high-risk endometrial cancer.

A phase 3 study evaluating uproleselan in relapsed/refractory acute myeloid leukemia missed its primary end point of overall survival.

If approved, zenocutuzumab would be the first targeted therapy for neuregulin 1 fusion-positive lung and pancreatic cancers.

The American Urological Association Annual Meeting took place May 3-6, 2024, in San Antonio, Texas, where data across the field of urologic oncology were presented.

Apalutamide with androgen deprivation therapy following radical prostatectomy led to a biochemical recurrence-free survival rate of 100% after 2 years among patients with high-risk prostate cancer.

Findings from a real-world study identified that venetoclax was a safe treatment option and did not lead to higher rates of death for patients with chronic lymphocytic leukemia who were diagnosed with COVID-19.

Acalabrutinib plus bendamustine and rituximab bettered progression-free survival over bendamustine and rituximab alone in patients with untreated mantle cell lymphoma.

C. Ola Landgren, MD, PhD, discussed the FDA’s unanimous ODAC vote supporting minimal residual disease as an accelerated approval end point in multiple myeloma and the implications of this vote in the myeloma research field.

Nivolumab monotherapy plus salvage nivolumab/ipilimumab demonstrated superior treatment-free survival rates among patients with advanced renal cell carcinoma, especially in patients with favorable risk profiles.

Recently published guidelines from the FDA aim to expand eligibility criteria in clinical trials with recommendations for laboratory values, washout periods, and patient performance status.

Cellular therapies are an effective option in hematologic malignancies but have been slower to develop in AML, but identifying new targets paves the way for evolving treatments.

Following its recent FDA approval in non-muscle-invasive bladder cancer, nogapendekin alfa has also shown overall survival benefits in addition to checkpoint inhibitor therapy in patients with non-small cell lung cancer.

Warren Fingrut, MD, discussed a study looking at HLA antibody burden among patients with blood cancers, particularly women who have carried multiple pregnancies.

The FDA has approved the new drug application of tovorafenib for the treatment of pediatric low-grade glioma.