Oncology

NF2-related schwannomatosis is a relentlessly progressive tumor predisposition syndrome with no FDA-approved treatments.

Phase III innovaTV 301/ENGOT-cx12/GOG-3057 trial findings indicate that Tivdak (tisotumab vedotin-tftv) may be the preferred second- or third-line treatment option over chemotherapy for patients with recurrent cervical cancer.

Phase III trial data shows significant survival benefit with Rybrevant plus Leclaza compared to Tagrisso in the treatment of patients with previously untreated or Tagrisso-pretreated epidermal growth factor receptor–mutated advanced non–small-cell lung cancer.

Imfinzi (durvalumab; AstraZeneca) combined with chemotherapy led to a statistically significant and clinically meaningful improvement in event-free survival and overall survival compared with neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer.

The CAPItello-290 Phase III trial evaluated Truqap in combination with chemotherapy compared to placebo and chemotherapy for the treatment of locally advanced or metastatic triple-negative breast cancer.

Columvi with gemcitabine and oxaliplatin (GemOx) achieved statistically significant and clinically meaningful outcomes treating relapsed or refractory diffuse large B-cell lymphoma compared to MabThera/Rituxan plus GemOx.

Linvoseltamab was previously granted Priority Review by the FDA for adults with relapsed/refractory multiple myeloma who experienced disease progression following prior administration of at least three therapies.

Elrexfio is a BCMA-CD3-targeted bispecific antibody that the FDA granted accelerated approval in August 2023 to treat patients with relapsed or refractory multiple myeloma who were previously administered at least four lines of therapy.

Results from the Phase II PICCOLO trial show the promise of Elahere (mirvetuximab soravtansine; AbbVie) in heavily pre-treated patients with folate receptor-alpha positive, platinum-sensitive ovarian cancer.

Enhertu achieved statistically significant and clinically meaningful improvements in progression-free survival compared with standard-of-care chemotherapy among patients with HR-positive, HER2-low metastatic breast cancer.

Results from the Phase III CheckMate -9DW trial show Opdivo plus Yervoy produced a statistically significant and clinically meaningful improvement in overall survival compared with investigator’s choice of sorafenib or lenvatinib in the first-line treatment of unresectable hepatocellular carcinoma.

Tagrisso (osimertinib; AstraZeneca) reduced the risk of disease progression or death by 84% in patients with unresectable, stage III epidermal growth factor receptor-mutated (non-small cell lung cancer with tumors that harbor exon 19 deletions or exon 21 (L858R) mutations.

Results of the Phase III CheckMate -77T, CheckMate -816, and CheckMate -9LA trials show the potential of Opdivo to improve survival among patients with early and advanced stages of lung cancer.

Approval of Breyanzi (lisocabtagene maraleucel) to treat adults with relapsed or refractory mantle cell lymphoma was based on findings from the open-label, multicenter, pivotal TRANSCEND NHL 001 trial.

Sarclisa (isatuximab-irfc) could become the first anti-CD38 therapy indicated in combination with bortezomib, lenalidomide, and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for a transplant.

Keytruda (pembrolizumab; Merck) plus chemotherapy administered as neoadjuvant treatment and then as monotherapy postsurgery produced a statistically significant improvement in overall survival in patients with high-risk early-stage triple-negative breast cancer.

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.