Chris Ryan

The FDA has placed a full clinical hold on a phase 1 dose escalation trial investigating the BRG1/BRM inhibitor FHD-286 in patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome.

The novel third-generation EGFR inhibitor abivertinib generated a positive overall response rate and overall survival in heavily pretreated Chinese patients with EGFR T790M–mutated non–small cell lung cancer who failed treatment on a first-line EGFR TKI, according to long-term follow-up data from a phase 1/2 trial (NCT02330367).

The European Medicines Agency has validated the marketing authorization application for quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of adult patients with newly diagnosed FLT3-ITD–mutated acute myeloid leukemia.

The FDA has lifted a partial clinical hold on the open-label, dose-escalating phase 1/2 TakeAim Lymphoma trial investigating the safety and efficacy of emavusertib in patients with relapsed or refractory B-cell malignancies.

The FDA has accepted a new drug application for momelotinib for the treatment of patients with myelofibrosis.

The Guardant Reveal assay has been expanded for the detection of minimal residual disease and disease recurrence in patients with early-stage breast cancer and lung cancer.

The FDA has approved the Oncomine Dx Target Test as a companion diagnostic to identify patients with NSCLC harboring an activating HER2 mutation who may derive clinical benefit from treatment with fam-trastuzumab deruxtecan-nxki.

The FDA has accepted a supplemental biologics license application for the combination of polatuzumab vedotin and R-CHP as a treatment for patients with previously untreated diffuse large B-cell lymphoma.

Sacituzumab govitecan elicited a statistically significant and clinically meaningful improvement in overall survival vs standard chemotherapy in patients with hormone receptor–positive, HER2-negative breast cancer who received prior treatment with endocrine therapy, CDK4/6 inhibitors, and 2 to 4 lines of chemotherapy, according to findings from the second interim analysis of the phase 3 TROPiCS-02 trial.

The anti–interleukin-1β monoclonal antibody canakinumab did not generate a disease-free survival benefit vs placebo in adult patients with stages II to IIIA and IIIB completely resected non–small cell lung cancer, failing to meet the primary end point of the phase 3 CANOPY-A trial.

Pembrolizumab monotherapy continued to demonstrate durable antitumor activity with promising overall survival in patients with advanced hepatocellular carcinoma who received prior treatment with sorafenib, according to updated data from cohort 1 of the phase 2 KEYNOTE-224 trial.

Single-agent tolinapant generated promising response rates with a manageable safety profile in patients with relapsed/refractory peripheral T-cell lymphoma and cutaneous T-cell lymphoma, according to data from the phase 2 ASTX660-01 trial.

The FDA has expanded its approval of the VENTANA MMR RxDx panel to identify patients with mismatch repair–deficient solid tumors and as a companion diagnostic assay to determine eligibility for pembrolizumab as a treatment for patients with mismatch repair–proficient endometrial cancer.

Idecabtagene vicleucel elicited a statistically significant improvement in progression-free survival vs standard combination regimens in patients with relapsed/refractory multiple myeloma who had received 2 to 4 lines of prior therapy.

Treatment with durvalumab and concurrent radiotherapy provided a significant benefit in progression-free survival in patients with locally advanced non–small cell lung cancer, meeting the primary end point of the phase 2 DOLPHIN trial.

Sunvozertinib monotherapy produced meaningful responses in patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations who received prior treatment with platinum-based chemotherapy, according to pooled data from the phase 1 WU-KONG1 and WU-KONG2 trials, plus the phase 2 WU-KONG6 trial.

The combination of datopotamab deruxtecan and pembrolizumab, with or without platinum-based chemotherapy, displayed promising efficacy and a manageable safety profile in patients with advanced/metastatic non–small cell lung cancer.

GDC-6036, a novel KRAS G12C inhibitor, produced encouraging antitumor activity with a manageable safety profile as a single agent in previously treated patients with KRAS G12C–mutated NSCLC, according to data from a phase 1a trial.

Second- or third-line tislelizumab continued to display an overall survival benefit vs docetaxel in patients with non–small cell lung cancer.

The European Commission has approved olaparib as a single agent or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutated, HER2-negative, high-risk early breast cancer.

Liposomal irinotecan did not provide an overall survival benefit compared with topotecan as a second-line treatment for patients with small cell lung cancer who progressed on or after first-line platinum-based chemotherapy.

Eftilagimod alpha plus pembrolizumab demonstrated promising benefits in overall survival and progression-free survival as a second-line treatment in patients with non–small cell lung cancer who progressed on anti–PD-1/anti–PD-L1 therapy.

Poziotinib produced an encouraging overall response rate in patients with non–small cell lung cancer harboring EGFR exon 20 mutations, meeting the primary end point in cohort 1 of a phase 2 trial.

The subcutaneous administration of atezolizumab produced non-inferior levels of the agent in the blood compared with intravenous atezolizumab in immunotherapy-naïve patients with locally advanced or metastatic non–small cell lung cancer who failed platinum-based chemotherapy.

The FDA has accepted a priority review of a biologics license application for omidubicel as a treatment for patients with blood cancers in need of allogenic hematopoietic stem cell transplant.

The FDA has lifted a clinical hold on the phase 1b KEYNOTE-B79 trial, which is evaluating the safety and clinical activity of CYAD-101 given concurrently with FOLFOX and followed by pembrolizumab in patients with unresectable metastatic colorectal cancer.

The combination of nivolumab and ipilimumab failed to elicit a statistically significant improvement in disease-free survival compared with placebo as adjuvant treatment in patients with localized renal cell carcinoma who had undergone a full or partial removal of the kidney and were at moderate or high risk of relapse, failing to meet the primary end point of part A of the phase 3 CheckMate-914 trial.

Leveraging EGFR TKIs as a backbone for combination therapies will be pivotal for expanding treatment options and delivering more personalized therapies in the first-line setting for patients with non–small cell lung cancer harboring EGFR mutations.

PD-L1 and tumor mutational burden are established biomarkers for leveraging immunotherapy in non–small cell lung cancer; however, their use may not be appropriate in determining treatment decisions for all patients.

Thought minimal residual disease can serve as an indicator for poor outcomes for patients with non–small cell lung cancer, it is not necessarily a predictor of response to immunotherapy.