The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.
Ide-Cel Provides HRQOL Benefits Over Standard Regimens in R/R Multiple Myeloma
December 9th 2023Idecabtagene vicleucel resulted in meaningful improvements in symptoms, functioning, overall health status, and health-related quality of life vs standard regimens in select patients with triple-class exposed relapsed/refractory multiple myeloma, according to updated data from the phase 3 KarMMa-3 trial.
Bridging Therapy Prior to Axi-Cel Produces Favorable Real-World Outcomes in R/R LBCL
December 9th 2023Although the use of bridging therapy prior to treatment with axicabtagene ciloleucel did not improve efficacy or safety outcomes for patients with relapsed/refractory large B-cell lymphoma, responses to bridging therapy may be prognostic of favorable outcomes after axi-cel administration.
Revumenib Combo Showcases Early Activity in Relapsed/Refractory AML
December 9th 2023Revumenib, decitabine/cedazuridine, plus venetoclax elicited an objective response rate of 100% with acceptable safety in patients with relapsed/refractory acute myeloid leukemia enrolled in the small phase 1/2 SAVE study.
Real-World Analysis Sheds Light on Safety and Efficacy of Teclistamab in R/R Multiple Myeloma
December 9th 2023The T-cell redirecting bispecific antibody teclistamab-cqyv demonstrated efficacy and a tolerable safety profile in a real-world population of patients with relapsed/refractory multiple myeloma consistent with that of those enrolled in the phase 2 MajesTEC-1 trial.
AI Algorithm Effectively Differentiates Between pre-PMF/ET
December 9th 2023A machine learning, artificial intelligence algorithm analyzing diagnostic bone marrow biopsy digital whole-slide images was able to effectively differentiate with 92.3% accuracy between prefibrotic primary myelofibrosis and essential thrombocythemia.
Neoadjuvant Nivolumab Plus Carboplatin/Paclitaxel Elicits High pCR Rates in Early-Stage TNBC
December 8th 2023Neoadjuvant nivolumab and non–anthracycline containing chemotherapy produced promising pathologic complete response rates regardless of whether nivolumab was administered before or during treatment with carboplatin and paclitaxel in patients with stage I to IIB triple-negative breast cancer.
Zanidatamab Triplet Shows Positive PFS Outcomes in HR+/HER2+ Metastatic Breast Cancer
December 8th 2023Zanidatamab in combination with palbociclib and fulvestrant resulted in positive progression-free survival outcomes and exhibited an acceptable safety profile in patients with hormone receptor–positive, HER2-positive metastatic breast cancer.
Atezolizumab Plus Neoadjuvant HP/Chemo Does Not Significantly Improve pCR in HER2+ Breast Cancer
December 8th 2023The addition of atezolizumab to neoadjuvant trastuzumab plus pertuzumab (HP) and chemotherapy led to a numerical, but not statistically significant, increase in pathologic complete response vs HP/chemotherapy alone in patients with HER2-positive operable breast cancer.
Adjuvant T-DM1 Provides Sustained Survival Benefit in HER2+ Early Breast Cancer
December 8th 2023Adjuvant ado-trastuzumab emtansine continued to improve overall survival and invasive disease-free survival vs trastuzumab after 8.4 years of follow-up in patients with HER2-positive early breast cancer and residual invasive disease following neoadjuvant therapy enrolled in the phase 3 KATHERINE trial.
SIM0270 Demonstrates Early Antitumor Activity in ER+/HER2– Advanced/Metastatic Breast Cancer
December 8th 2023The brain-penetrant oral selective estrogen receptor degrader SIM0270 exhibited a favorable safety profile and early signals of antitumor activity in patients with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer, including those with ESR1 mutations.
Ribociclib Plus Nonsteroidal Aromatase Inhibitor Improves iDFS in HR+ HER2- Early Breast Cancer
December 8th 2023A continued statistically significant improvement in iDFS was observed for patients with HR-positive, HER2-negative early-stage breast cancer who received ribociclib plus a nonsteroidal AI vs a nonsteroidal AI alone, according to the final iDFS analysis of the phase 3 NATALEE trial.
Elacestrant Improves PFS in ESR1-Mutant Metastatic Breast Cancer Subgroups
December 8th 2023Treatment with elacestrant led to a clinically meaningful improvement in progression-free-survival compared with standard-of-care therapy among patients with estrogen receptor–positive/HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
T-DXd Yields Early Activity in HER2+/HER2-Low Breast Cancer With Leptomeningeal Carcinomatosis
December 7th 2023Treatment with trastuzumab deruxtecan generated clinical responses in patients with HER2-low or HER2-positive advanced breast cancer with pathologically confirmed leptomeningeal carcinomatosis.
Datopotamab Deruxtecan Prolongs PFS in HR+/HER2- Inoperable or Metastatic Breast Cancer
December 7th 2023Datopotamab deruxtecan resulted in a statistically significant and clinically meaningful improvement in progression-free survival compared with chemotherapy among patients with previously treated, hormone receptor-positive/HER2-negative inoperable or metastatic breast cancer.
Inavolisib Plus Palbociclib and Fulvestrant Improves PFS in PIK3CA-Mutated HR+ Breast Cancer
December 7th 2023The addition of inavolisib to palbociclib and fulvestrant improved progression-free survival vs palbociclib and fulvestrant alone in select patients with PIK3CA-mutated, hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer.
T-DXd Demonstrates Real-World Efficacy in Advanced Breast Cancer With Dynamic HER2 Expression
December 7th 2023Administration of fam-trastuzumab deruxtecan significantly prolonged time-to-next treatment in patients with HER2-positive or HER2-low metastatic breast cancer, including patients who experienced changes in HER2 status during the treatment course.
Nivolumab Plus Ipilimumab Improves PFS in Newly Diagnosed Metastatic Colorectal Cancer
December 7th 2023The combination of nivolumab and ipilimumab led to a statistically significant and clinically meaningful improvement in progression-free survival per blinded independent central review compared with investigator’s choice of chemotherapy as frontline therapy in patients with metastatic colorectal cancer.
PFS Benefit Observed With Tucatinib Plus T-DM1 in Previously Treated HER2+ Metastatic Breast Cancer
December 6th 2023The addition of tucatinib to ado-trastuzumab emtansine (T-DM1) significantly improved progression-free survival vs placebo plus T-DM1 in patients with previously treated HER2-positive metastatic breast cancer, including those with brain metastases.