Oncology

CAR T-cell therapy obecabtagene autoleucel produced high response rates, durable outcomes, and low toxicity in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia, especially benefiting those with low-to-intermediate bone marrow burden.

Phase III CheckMate 8HW trial results demonstrated that the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) significantly improves progression-free survival and has a better safety profile compared to chemotherapy in the first-line treatment of MSI-H or dMMR metastatic colorectal cancer.

Results from a followup evaluation of COLOFOL trial show no significant improvement in 10-year overall or colorectal cancer–specific mortality rates between high-frequency and low-frequency postoperative follow-up regimens for patients with stage II or III colorectal cancer.

Phase III DREAMM-7 trial data show that the combination of Blenrep (belantamab mafodotin) with bortezomib and dexamethasone (BorDex) significantly improved overall survival in patients with relapsed or refractory multiple myeloma compared to standard treatment with Darzalex (daratumumab) and BorDex.

Phase III COMBI-AD trial final analysis shows that 12 months of adjuvant therapy with Tafinlar (dabrafenib) and Mekinist (trametinib) in patients with resected stage III melanoma significantly improved relapse-free survival and distant metastasis-free survival compared to placebo.

INAVO120 Phase III trial shows Itovebi (inavolisib) plus Ibrance (palbociclib) and Faslodex (fulvestrant) is a promising first-line treatment option that effectively targets disease pathways with durable clinical benefits for PIK3CA-mutated, endocrine-resistant, HR-positive, HER2-negative metastatic breast cancer.

The combination of Opdivo (nivolumab) plus chemotherapy significantly improved progression-free survival compared to Adcetris (brentuximab vedotin) plus chemotherapy in patients with advanced stage Hodgkin lymphoma, based on findings from the Phase III S1826 trial.

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.