Kristi Rosa

MRT-2359 had acceptable tolerability with a favorable pharmacokinetic and pharmacodynamic profile in heavily pretreated patients with MYC-driven solid tumors, including lung cancer and high-grade neuroendocrine cancer.

Volrustomig demonstrated efficacy when used as frontline treatment in patients with clear cell renal cell carcinoma with a toxicity profile that is consistent with dual checkpoint inhibition.

The FDA has approved repotrectinib (Augtyro) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non–small cell lung cancer.

Concurrent administration of durvalumab and platinum-based chemoradiation failed to significantly improve progression-free survival over chemoradiation alone in patients with unresectable stage III non–small cell lung cancer, missing the primary end point of the phase 3 PACIFIC-2 trial.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion supporting the approval of momelotinib for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anemia with primary myelofibrosis, post–polycythemia vera myelofibrosis, or post–essential thrombocytopenia myelofibrosis who have not been exposed to a JAK inhibitor or who had received prior ruxolitinib.

After a re-examination procedure, the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion on the conditional marketing authorization application for adagrasib in the treatment of adult patients with KRAS G12C–mutated advanced non–small cell lung cancer whose disease progressed following at least 1 prior systemic treatment.

Bayer has announced the intention to voluntarily withdraw the new drug application for copanlisib in adult patients with relapsed follicular lymphoma who have previously received at least 2 prior systemic treatments.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of pembrolizumab (Keytruda) combined with gemcitabine and cisplatin in the frontline treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer

The combination of PDS0101, PDS0301 (formerly M-9241), and bintrafusp alfa, an investigational immune checkpoint inhibitor extended survival in patients with advanced human papillomavirus 16–positive cancers, according to final data from a phase 2 trial (NCT04287868) led by the National Cancer Institute.

Durvalumab plus concurrent transarterial chemoembolization followed by durvalumab with bevacizumab resulted in a significant improvement in PFS over TACE alone in patients with hepatocellular carcinoma who are eligible for embolization, meeting the primary end point of the phase 3 EMERALD-1 trial.

The FDA has granted priority review to the supplemental biologics license application seeking approval to expand the indication of lisocabtagene maraleucel to include patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who had prior exposure to a BTK inhibitor and a BCL-2 inhibitor.

The combination of inetetamab, pertuzumab, paclitaxel, and carboplatin elicited responses with an acceptable safety profile when administered as neoadjuvant treatment in patients with locally advanced HER2-positive breast cancer.

CMG901 induced responses with a manageable toxicity profile in patients with CLDN18.2-positive gastric or gastroesophageal junction cancer, according to updated data from the dose-expansion phase of the phase 1 KYM901 study.

Treatment with vic-trastuzumab duocarmazine demonstrated a trend toward numerically prolonged overall survival compared with physician’s choice of treatment in patients with pretreated HER2-positive metastatic breast cancer.

The combination of garsorasib and cetuximab elicited responses and was found to be well tolerated in heavily pretreated patients with KRAS G12C–mutated colorectal cancer.

The Claudin-6–directed CAR T-cell therapy, BNT211, showed signs of clinical activity in patients with CLDN6-positive relapsed or refractory solid tumors.

The addition of atezolizumab to bevacizumab and chemotherapy resulted in a significant improvement in progression-free survival and overall survival vs standard treatment with bevacizumab and chemotherapy in patients with metastatic, persistent, or recurrent cervical cancer.

The FDA has approved pembrolizumab (Keytruda) plus gemcitabine and cisplatin for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer.

The FDA has granted breakthrough therapy designation to furmonertinib for use as a potential therapeutic option in patients with previously untreated, locally advanced or metastatic nonsquamous non–small cell lung cancer harboring EGFR exon 20 insertion mutations.

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.