FDA Green Lights NGS-Based Companion Diagnostic for Trastuzumab Deruxtecan in HER2-Mutated NSCLC
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.
FDA Accepts sBLA for Polatuzumab Vedotin Plus R-CHP in Untreated DLBCL
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 Prolongs OS in Heavily Pretreated HR+ Breast Cancer
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.
Canakinumab Fails to Meet DFS End Point in Resected NSCLC
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.
Single-Agent Pembrolizumab Maintains Survival Benefit in Sorafenib-Pretreated Advanced HCC
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.
Tolinapant Displays Encouraging Activity and Safety in Relapsed/Refractory PTCL/CTCL
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.
FDA Approves VENTANA MMR RxDx To Identify dMMR Solid Tumors and as Companion Diagnostic for pMMR Endometrial Cancer
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.
Ide-cel Produces PFS Benefit Vs Standard Regimens in Relapsed/Refractory Multiple Myeloma
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.
Durvalumab Plus Concurrent Radiotherapy Meets PFS End Point in Locally Advanced NSCLC
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.
Single-Agent Sunvozertinib Elicits Responses in Advanced NSCLC Harboring EGFR Exon 20 Insertion Mutations
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.
Datopotamab Deruxtecan/Pembrolizumab With or Without Chemotherapy Elicits Responses in Advanced NSCLC
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 Monotherapy Elicits Promising Responses in KRAS G12C–Mutant NSCLC
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.
Tislelizumab Maintains OS Benefit Vs Docetaxel in Previously Treated NSCLC
Second- or third-line tislelizumab continued to display an overall survival benefit vs docetaxel in patients with non–small cell lung cancer.
EU Approves Adjuvant Olaparib for BRCA-Mutated, HER2-Negative Early Breast 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.
Single-Agent Liposomal Irinotecan Fails to Meet OS End Point in Second-Line Treatment of SCLC
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/Pembrolizumab Combo Elicits Encouraging Survival Benefits in Anti–PD-1/PD-L1 Refractory NSCLC
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 Elicits Encouraging Responses in EGFR Exon 20–Mutated NSCLC
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.
Subcutaneous Atezolizumab Produces Noninferior Pharmacokinetics Vs IV Atezolizumab in NSCLC
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.
FDA Grants Priority Review to Omidubicel for Blood Cancers Requiring Transplant
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.
FDA Lifts Clinical Hold on KEYNOTE-B79 Trial Evaluating CAR T-cell Therapy CYAD-101 in Metastatic CRC
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.
Adjuvant Nivolumab/Ipilimumab Fails to Meet DFS End Point in Localized RCC
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.
EGFR TKI–Based Combos Could Lead to More Tailored First-Line Treatment Options in EGFR-Mutated NSCLC
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.
Novel Biomarker Testing Could Enhance Immunotherapy Treatment Decisions in NSCLC
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.
MRD Status Alone Is Not Necessarily Predictive of Response to Immunotherapy in NSCLC
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.
Novel Agents Needed to Expand Treatment Options for Patients With High-Risk MDS
Dan Pollyea, MD, MS, discussed the difficulties in developing new agents for the treatment of high-risk MDS, the objective of the ENHANCE trial, and the potential for other therapies to emerge in the treatment paradigm.
SHR3680 Plus ADT Improves Survival Vs Bicalutamide/ADT in High-Volume mHSPC
The addition of SHR3680 to androgen deprivation therapy significantly improved radiographic progression-free survival and overall survival compared with bicalutamide plus ADT in patients with high-volume, metastatic hormone-sensitive prostate cancer, according to data from the phase 3 CHART trial.
Niraparib Maintenance Prolongs PFS in Newly Diagnosed Advanced Ovarian Cancer After Response to Chemotherapy
Maintenance therapy with niraparib significantly improved progression-free survival compared with placebo in Chinese patients with newly diagnosed advanced ovarian cancer who achieved a complete response or partial response to first-line chemotherapy.
Zilovertamab/Ibrutinib Combo Under Exploration to Fill Unmet Need in Relapsed/Refractory MCL
The addition of zilovertamab to ibrutinib will be compared with ibrutinib plus placebo in patients with relapsed/refractory mantle cell lymphoma as part of the phase 3 ZILO-301 trial.
Teclistamab Approaches EU Approval for Relapsed/Refractory Multiple Myeloma
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the conditional marketing authorization of teclistamab for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and whose cancer has worsened since receiving the last treatment.
FDA Grants Orphan Drug Designation to DSP-0390 for Brain Cancer
The FDA has granted an orphan drug designation to DSP-0390 for the treatment of brain cancer.
Immunotherapy Must Become More Precise and Personalized in Lung Cancer
Selecting the Appropriate CAR T-Cell Therapy for Patients with R/R LBCL
Is There a Potential Role for Rapcabtagene Autoleucel in R/R LBCL?
PD-1 Inhibitor Combinations, Alternative Therapeutic Approaches Are Moving the Needle in NSCLC
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