Oncology

Columvi with gemcitabine and oxaliplatin showed the potential to improve survival in patients with relapsed or refractory diffuse large B-cell lymphoma who are not candidates for autologous stem cell transplant.

Findings from the Phase I/II KRYSTAL-1 trial of Krazati (adagrasib) plus cetuximab showed promising clinical activity and tolerable safety in patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer.

Trial to analyze novel therapy MK-1084 plus Keytruda (pembrolizumab) in certain patients with metastatic non-small cell lung cancer whose tumors harbor KRAS G12C mutations and express PD-L1.

Raludotatug deruxtecan is a potential first-in-class CDH6-directed antibody drug conjugate that has shown promise in patients with CDH6-expressing serous-type ovarian cancer and renal cell carcinoma.

The investigational TROP2-directed antibody drug conjugate improved progression-free survival in patients with unresectable or metastatic HR-positive, HER2-negative breast cancer.

Krazati (adagrasib) was previously granted accelerated approval by the FDA to treat patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer who were previously administered at least one systemic therapy.

Odronextamab is being evaluated for the treatment of relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma following two or more prior lines of systemic therapy.

Opdivo plus Yervoy was found to produce a statistically significant and clinically meaningful overall survival improvement compared with sorafenib or lenvatinib in patients with advanced hepatocellular carcinoma.

Pivotal Phase III Study 302 trial data show an objective response rate of 36.2% based on an independent review committee assessment in the treatment of relapsed/refractory cutaneous T-cell lymphoma.

Jemperli plus chemotherapy with or without adding maintenance treatment with Zejula produced a statistically significant overall survival and progression-free survival benefit in patients with primary advanced or recurrent endometrial cancer.

Keytruda plus chemoradiotherapy found to significantly improve overall survival in patients newly diagnosed with high-risk locally advanced cervical cancer.

Adcetris (brentuximab vedotin) plus lenalidomide and rituximab produced statistically significant and clinically meaningful improvements in overall survival in patients with relapsed or refractory diffuse large B-cell lymphoma.

Blenrep (belantamab mafodotin) combined with pomalidomide plus dexamethasone showed favorable progression-free survival compared with standard of care in the second-line and later treatment of relapsed or refractory multiple myeloma.

The FDA previously halted the IOV-LUN-202 trial following reports of a grade 5 serious adverse event that may have been linked to treatment with Iovance Biotherapeutics’ novel tumor infiltrating lymphocyte cell therapy LN-145, which is being evaluated in patients with advanced non–small cell lung cancer.

Data from a pair of Phase III trials indicated a progression-free survival and complete response advantage in favor of Brukinsa in patients with relapsed or refractory chronic lymphocytic leukemia.

The FDA has taken a clear position with Project Optimus in shifting toward more progressive tailored approaches while rejecting antiquated study designs to evolve clinical trial strategies to better align with newer drug classes.

Epkinly (epcoritamab-bysp), subcutaneously administered, T-cell engaging, IgG1-bispecific antibody, was previously granted Breakthrough Therapy Designation for the treatment of patients with relapsed or refractory follicular lymphoma.

Ocifisertib has shown significant single-agent activity in both solid and liquid tumors.

The Phase I/II MajesTEC-1 trial (NCT03145181; NCT04557098) evaluated Tecvayli (teclistamab-cqyv) at a reduced dose of 1.5 mg/kg administered every two weeks in patients with relapsed/refractory multiple myeloma.

Data from the pivotal, global, randomized, double-blind, placebo-controlled, Phase III INDIGO trial show statistically significant and clinically meaningful progression-free survival for vorasidenib treating IDH-mutant gliomas.

Trial findings show Krazati (adagrasib) plus cetuximab was well tolerated with promising clinical activity among pretreated patients with locally advanced or metastatic colorectal cancer harboring a KRASG12C mutation

Datopotamab deruxtecan, the first TROP2-directed DXd antibody drug conjugate, is being evaluated for locally advanced or metastatic nonsquamous non-small cell lung cancer.

Results from the randomized, multicenter, open-label, Phase III FLAURA 2 trial show Tagrisso plus chemotherapy delayed disease progression by nearly nine additional months in adults with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer.

Amtagvi (lifileucel) is a personalized, one-time therapeutic option for adult patients with unresectable or metastatic melanoma who received prior treatment with a PD-1 antibody, and in patients who are BRAF V600-positive, a BRAF inhibitor with or without a MEK inhibitor.

Single-arm, open-label, multicenter, non-randomized, multicohort Phase II VISION trial (NCT02864992) of Tepmetko (tepotinib) for metastatic non–small cell lung cancer shows favorable objective response rate.

There were no safety or efficacy issues identified in the FDA's complete response letter for Lymphir, with no additional trials required.

Trials of Augtyro are ongoing for this tumor-agnostic indication, which could provide a durable treatment option for patients with NTRK-positive disease.

The Onivyde combination was evaluated in the open-label, multicenter, randomized Phase III NAPOLI 3 trial, showing significantly improved overall survival in patients with metastatic pancreatic adenocarcinoma.

Phase II trial data show positive survival results for BXCL701 combined with Keytruda (pembrolizumab) to treat patients with metastatic small cell neuroendocrine prostate cancer.

Samsung Biologics will provide antibody development and drug substance manufacturing services for LegoChem Biosciences' antibody-drug conjugate program with hopes of submitting an Investigational New Drug application to the FDA in 2025.