Kristi Rosa

The addition of dostarlimab to carboplatin plus paclitaxel followed by dostarlimab monotherapy significantly improved overall survival compared with placebo plus chemotherapy followed by placebo in adult patients with primary advanced or recurrent endometrial cancer.

The combination of ibrutinib and bortezomib elicited durable responses in patients with relapsed or refractory mantle cell lymphoma and high-risk features such as a Ki-67 over 30%, blastoid or pleomorphic variant, p53 overexpression, and TP53 mutations and/or deletions.

Datopotamab deruxtecan elicited encouraging responses in patients with heavily pretreated non–small cell lung cancer harboring actionable genomic alterations.

Vepdegestrant continued to showcase clinical activity with favorable tolerability spanning all doses examined in heavily pretreated patients with estrogen receptor–positive, HER2-negative advanced breast cancer, according to updated dose-escalation data from a phase 1/2 study.

The FDA has approved ivosidenib (Tibsovo) for the treatment of adult patients with relapsed/refractory myelodysplastic syndromes with a susceptible IDH1 mutation, as detected by an FDA-approved test.

Selpercatinib (Retevmo) showcased superior efficacy, with improved progression-free survival, vs chemotherapy with or without pembrolizumab in the first-line treatment of patients with RET fusion–positive non–small cell lung cancer.

The FDA has granted accelerated approval to entrectinib (Rozlytrek) for pediatric patients aged older than 1 month with solid tumors that harbor a NTRK gene fusion without a known acquired resistance mutation, are metastatic, or where surgical resection is likely to result in severe morbidity, and have progressed after treatment or have no satisfactory standard therapy options.

Dostarlimab plus chemotherapy elicited a higher objective response rate and showcased a numerical improvement in overall survival compared with pembrolizumab and chemotherapy in patients with treatment-naïve, nonsquamous non–small cell lung cancer.

The 2023 ESMO Congress, which is taking place in Madrid, Spain, and will continue to be accessible online via a virtual platform, is gearing up to kick off, and the oncology community is ready to learn more about the latest data across malignancies.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion regarding the approval of a Type II variation application for rucaparib as a frontline maintenance in patients with advanced ovarian cancer who have responded to first-line, platinum-based chemotherapy, irrespective of BRCA mutational status.

The FDA has approved pembrolizumab (Keytruda) in combination with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of pembrolizumab monotherapy as post-surgical adjuvant treatment for patients with resectable non–small cell lung cancer.

Lirafugratinib demonstrated clinical activity in multiple subsets of patients with FGFR2-altered solid tumors, including those with FGFR2-altered hormone receptor–positive, HER2-negative breast cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of zanubrutinib in combination with obinutuzumab for use in adult patients with relapsed or refractory follicular lymphoma who have previously received at least 2 lines of systemic treatment.

The FDA has approved encorafenib (Braftovi) plus binimetinib (Mektovi) for adult patients with metastatic non–small cell lung cancer harboring a BRAF V600E mutation, as detected by an FDA-approved test.

The addition of bexmarilimab to standard-of-care azacitidine or azacitidine plus venetoclax continued to elicit responses in patients with relapsed or refractory acute myeloid leukemia and those with myelodysplastic syndrome who were refractory to hypomethylating agents.

TJ-L14B/ABL503 demonstrated preliminary efficacy signals in the form of responses in patients with progressive, locally advanced or metastatic solid tumors who were relapsed or refractory after previous lines of therapy.

Pembrolizumab plus chemotherapy prior to surgery, followed by resection and single-agent pembrolizumab in the adjuvant setting, significantly improved overall survival vs neoadjuvant placebo plus chemotherapy followed by adjuvant placebo in patients with resectable stage II, IIIA, or IIIB (T3-4N2) non–small cell lung cancer, meeting the dual primary end point of the phase 3 KEYNOTE-671 trial.

The undetectable minimal residual disease ate achieved with bendamustine followed by obinutuzumab, acalabrutinib, and venetoclax increased as the regimen was continued as maintenance treatment in patients with relapsed or refractory chronic lymphocytic leukemia.

The combination of venetoclax and dexamethasone failed to significantly improve progression-free survival over pomalidomide plus dexamethasone in patients with t(11;14)-positive, relapsed or refractory multiple myeloma who have previously received at least 2 therapies.

A Type II extension of indication application seeking the approval of amivantamab in combination with carboplatin and pemetrexed for the frontline treatment of adult patients with advanced non–small cell lung cancer and activating EGFR exon 20 insertion mutations has been submitted to the European Medicines Agency.

The biologics license application seeking the approval of the on-body injector presentation of pegfilgrastim-cbqv, a biosimilar of pegfilgrastim, has been resubmitted to the FDA for review.

Administration of stereotactic ablative body radiotherapy to oligoprogressive lesions delayed a change in systemic therapy in patients with estrogen receptor–positive/HER2-negative breast cancer enrolled to the prospective phase 2 AVATAR trial.

The European Medicines Agency has validated the marketing authorization application for the use of imetelstat in the treatment of transfusion-dependent anemia in patients with lower-risk myelodysplastic syndrome.

Takeda has announced plans to voluntarily withdraw mobocertinib in the United States for adult patients with EGFR exon 20 insertion mutation–positive, locally advanced or metastatic non–small cell lung cancer whose disease has progressed on or following platinum-based chemotherapy.

A new drug application seeking the approval of fruquintinib for the treatment of adult patients with previously treated metastatic colorectal cancer has been submitted to Japan’s Ministry of Health, Labour, and Welfare.

The combination of iberdomide plus bortezomib and dexamethasone produced deep responses with a manageable toxicity profile in patients with transplant-ineligible, newly diagnosed multiple myeloma, according to data from the phase 1/2 CC-220-MM-001 trial presented at the 2023 International Myeloma Society Annual Meeting.

The FDA has granted fast track designation to IDE161 for use in adult patients with advanced or metastatic hormone receptor–positive, HER2-negative breast cancer harboring BRCA1/2 mutations who have progressed after at least 1 hormonal therapy, a CDK4/6 inhibitor, and a PARP inhibitor.

The phase 3 ENHANCE-2 trial examining the frontline combination of magrolimab and azacitidine vs physician’s choice of venetoclax with azacitidine or intensive chemotherapy in patients with acute myeloid leukemia and TP53 mutations has been discontinued, according to an announcement from Gilead Sciences.

The FDA has granted fast track designation to MYTX-011 for use as a potential therapeutic option in patients with non–small cell lung cancer and cMET overexpression.

Epcoritamab-bysp has been approved by the European Commission and Japan's Ministry of Health, Labour, and Welfare for the treatment of select patients with relapsed/refractory large B-cell lymphoma.