Oncology

Preliminary data from the Phase III IMforte trial show the combination of Zepzelca (lurbinectedin) plus Tecentriq (atezolizumab) significantly improved overall survival and progression-free survival in patients with extensive-stage small cell lung cancer.

Talzenna (talazoparib) with Xtandi (enzalutamide) produced a statistically significant improvement in overall survival among patients with metastatic castration-resistant prostate cancer, regardless of mutation status, making it the first combination of a PARP inhibitor and ARPI to achieve these results.

KEYNOTE-689 trial shows Keytruda (pembrolizumab) produced significantly improved event-free survival and major pathological response in patients with resected, locally advanced head and neck squamous cell carcinoma, marking the first Phase III trial to show meaningful results with an anti-PD-1 therapy in both the neoadjuvant and adjuvant settings.

Beqvez (fidanacogene elaparvovec), a one-time gene therapy, was approved by the FDA in April 2024 to treat adults with moderate to severe hemophilia B.

Recent study compared patient enrollment trends in industry- and federally sponsored oncology trials.

Results from the Phase III CARTITUDE-4 trial show Carvykti (ciltacabtagene autoleucel) is the first and only cell therapy to show an overall survival benefit compared to standard therapies for patients with relapsed or lenalidomide-refractory multiple myeloma.

Bristol Myers Squibb and 2seventy bio have ceased enrollment in the Phase III KarMMa-9 trial, stating that advances in induction therapies for newly diagnosed multiple myeloma have reduced the eligible patient population for the trial.

Phase III KEYNOTE-522 trial data show Keytruda (pembrolizumab) plus chemotherapy lowered the risk of death by 34% compared to chemotherapy alone in patients with high-risk early-stage triple-negative breast cancer.

Final guidance suggests sponsors select two doses for Phase II trials with additional data requirements.

Cabozantinib (Cabometyx, Cometriq) shows potential as a new standard of care for patients with advanced pancreatic neuroendocrine tumors and advanced extra-pancreatic neuroendocrine tumors in Phase III CABINET trial.

Results from the the Phase III NIAGARA trial show Imfinzi (durvalumab) is the first immunotherapy regimen to significantly extend overall survival in patients with muscle-invasive bladder cancer.

DESTINY-Breast12 trial results show Enhertu (trastuzumab deruxtecan) produced substantial overall and intracranial clinical activity in patients with HER2-positive metastatic breast cancer and brain metastases, supporting its potential use as a second-line treatment.

Results of a Phase II study of ponsegromab showed significant improvements in body weight, muscle function, and overall symptoms for patients with cancer cachexia, offering hope for a new targeted treatment.

Data from the Phase III HIMALAYA trial found the combination of Imfinzi plus Imjudo reduced the risk of death by 24% compared to sorafenib in patients with unresectable hepatocellular carcinoma.

Ten-year results from the Phase III CheckMate -067 trial reveal that the combination of Opdivo and Yervoy significantly improves overall survival in patients with advanced melanoma, offering the longest-reported survival data in this population.

Phase III ADRIATIC trial results show that Imfinzi (durvalumab) significantly improves overall survival and progression-free survival compared to placebo in patients with limited-stage small-cell lung cancer.

An exploratory analysis from the TROPION-Lung01 Phase III trial found that tumors expressing TROP2 were associated with significantly improved responses to datopotamab deruxtecan compared to docetaxel in patients with non-small cell lung cancer.

Results from the Phase III MARIPOSA study found that the combination therapy showed an 8% improvement in overall survival in non-small cell lung cancer compared to osimertinib.

Potential first-in-class B7-H3 directed antibody drug conjugate ifinatamab deruxtecan shows potential to improve outcomes for patients living with difficult-to-treat form of lung cancer.

Cohort study finds a superior tolerability profile with darolutamide compared to other androgen receptor inhibitors, which investigators said indicates an efficacy advantage in the treatment of nonmetastatic castration-resistant prostate cancer.

A higher percentage of patients with advanced clear-cell renal cell carcinoma administered Welireg were alive and without disease progression compared to everolimus at 12 and 18 months.

Cohort study shows Xtandi (enzalutamide) achieved statistically significant improvements in overall survival vs. abiraterone acetate in the treatment of metastatic castration-resistant prostate cancer.

Induction therapy comprised of Sarclisa (isatuximab-irfc; Sanofi) plus lenalidomide, bortezomib, and dexamethasone significantly improved progression-free survival from first randomization in transplant-eligible patients with newly diagnosed multiple myeloma.

Overcoming saturation in the cell therapy landscape.

Study shows efficacy of olanzapine in improving complete response rates and chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy regimens comprised of oxaliplatin, carboplatin, or irinotecan.

Tremfya dosing at an interval of every 16 weeks was noninferior to the standard every eight weeks dosing interval for maintenance of psoriasis disease control.

Multiple observational studies have shown that patients with cancer and a higher body mass index who were administered chemotherapy experienced improved survival compared to patients with normal body weight.

Phase III DREAMM 7 trial data show median progression-free survival of 36.6 months with Blenrep (belantamab mafodotin), bortezomib, and dexamethasone compared to 13.4 months with Darzalex (daratumumab), bortezomib, and dexamethasone.

Study explores the role of the gut microbiome in shaping immune responses and efficacy of immune checkpoint inhibitors in the treatment of multiple cancer types.

Blincyto was recently approved by the FDA to treat CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia.