Oncology

Panna Sharma, CEO of Lantern Pharma, discusses LP-284, using their RADR during testing, ensuring global use, and what the future holds.

Promising scientific advances are pacing oncology drug development.

The potential of PBPK modeling in answering key questions around these drugs.

Findings from the Phase III KEYNOTE-B21 trial show that Keytruda (pembrolizumab) plus chemotherapy as adjuvant therapy, with or without radiotherapy, administered to patients with newly diagnosed high-risk endometrial cancer following surgery with curative intent did not achieve superiority in disease-free survival over placebo.

For antibody drug conjugates to reach their full potential, developers should focus on addressing current challenges such as safety and efficacy.

Johnson & Johnson’s novel targeted therapy TAR-200 produced a greater than 80% complete response rate in patients with Bacillus Calmette-Guérin–unresponsive, high-risk non–muscle-invasive bladder cancer with carcinoma in situ.

The combination of Calquence (acalabrutinib; AstraZeneca) plus bendamustine and rituximab generated a clinically meaningful improvement in progression-free survival in the first-line treatment of adults with mantle cell lymphoma.

Phase III KEYNOTE-811 trial data show Keytruda (pembrolizumab) combined with trastuzumab and chemotherapy achieved the primary endpoint of overall survival in the first-line treatment of patients with HER2-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Enhertu, a HER2-directed antibody-drug conjugate, showed a clinically meaningful survival benefit in progression-free survival among patients with HR-positive, HER2-low metastatic breast cancer.

Phase II/III COMPANION-002 trial shows promise of CTX-009 in combination with paclitaxel for patients with metastatic or locally advanced biliary tract cancer.

Data from part one of the Phase III RUBY trial show Jemperli (dostarlimab) plus chemotherapy produced a statistically significant and clinically meaningful survival benefit in patients with primary advanced or recurrent endometrial cancer, including those with mismatch repair proficient/microsatellite stable tumors.

Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.

Meta-analysis shows neoadjuvant immune checkpoint inhibitors with chemotherapy improves two-year event-free survival and pathologic complete response in patients with early-stage non–small cell lung cancer.

Imfinzi (durvalumab; AstraZeneca) plus gemcitabine and cisplatin was found to double the overall survival rate after three years in patients with advanced biliary tract cancer.

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.