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Showing 1501 - 1550Benefits Seen With Lurbinectedin Plus Doxorubicin in Small Cell Lung Cancer—but Primary Endpoint Missed
As a second-line treatment for patients with small cell lung cancer, lurbinectedin plus doxorubicin failed to improve overall survival in the multicenter ATLANTIS trial but did provide other benefits, including better tolerability, researchers reported at the 2021 World Conference on Lung Cancer,...
Adjuvant Pembrolizumab Shows Efficacy in High-Risk Stage II Melanoma in Adults and Children Older Than 12
Adjuvant pembrolizumab reduced the risk of recurrence in adults and children older than age 12 with high-risk stage II (AJCC 8th edition, stage IIB/IIC) melanoma vs placebo, according to a late-breaking interim analysis of the phase III KEYNOTE-716 trial, presented during the European Society for...
Expert Point of View: Mansoor Raza Mirza, MD
“The standard of care [in advanced cervical cancer] has been the addition of bevacizumab to platinum-based chemotherapy since 2014. Even with the addition of bevacizumab, we still need to do better. There is a substantial unmet need for new therapies,” said invited discussant Mansoor Raza Mirza,...
Study Shows Pembrolizumab Plus Chemotherapy Improves Survival in Advanced Cervical Cancer
The addition of pembrolizumab to chemotherapy prolonged survival in recurrent, persistent, or metastatic cervical cancer, according to the results of the first interim analysis of the KEYNOTE-826 trial, presented at a Presidential Symposium during the European Society for Medical Oncology (ESMO)...
Phase III Trial Supports Adjuvant Endocrine Therapy for 7 Years in Early-Stage Breast Cancer
For patients with early-stage hormone receptor–positive breast cancer, extending the duration of letrozole after tamoxifen—for up to 8 years of total endocrine therapy—significantly improved invasive disease–free survival over the standard 5 or so years, according to the final analysis of the...
IMpower010: Benefits Observed With Atezolizumab Regardless of Stage, Type of Prior Treatment
In an exploratory analysis of the pivotal phase III IMpower010 trial in stage II–IIIA non–small cell lung cancer (NSCLC), continued treatment with the monoclonal antibody atezolizumab after surgery and chemotherapy improved disease-free survival regardless of the type of surgery or chemotherapy...
DESTINY Breast03 Trial Supports Second-Line Use of T-DXd in Metastatic HER2-Positive Breast Cancer
The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) may become a new option as a second-line treatment of patients with HER2-positive unresectable or metastatic breast cancer, based on results from the global phase III DESTINY-Breast03 trial. These findings were presented by Javier...
FDA Pipeline: Recent Reviews, Designations, Applications, and Authorizations in the Oncology Space
Over the past month, the U.S. Food and Drug Administration (FDA) issued several regulatory decisions for novel treatments for patients with cancer. Priority Review for Relatlimab and Nivolumab Fixed-Dose Combination in Unresectable or Metastatic Melanoma The FDA accepted for Priority Review the...
ARAMIS Analysis: Darolutamide Shows Similar Benefits for Black Patients as Observed in the Overall Population
Black patients with prostate cancer who were treated with the androgen receptor inhibitor darolutamide had clinical outcomes similar to those observed in the overall clinical trial population, according to results from the phase III ARAMIS trial presented by Neal Shore, MD, at the 14th AACR...
Tackling a Growing Need: Options After CAR T-Cell Therapy for Lymphoma
For aggressive B-cell lymphomas, chimeric antigen receptor (CAR) T-cell therapy saves lives, but relapse remains common, and a second-line standard of care is lacking. During the 2021 Pan Pacific Lymphoma Conference, Grzegorz (Greg) S. Nowakowski, MD, Professor of Medicine and Oncology, Lymphoma...
Rates of Postprotocol Immunotherapy Use in Patients Enrolled in Kidney Cancer Clinical Trials
In an analysis reported in JAMA Network Open, Sharp et al identified the frequency of use of postprotocol PD-1/PD-L1 inhibitors in control group patients receiving the tyrosine kinase inhibitor sunitinib in randomized trials comparing PD-1/PD-L1 inhibitor–containing combination therapy vs sunitinib ...
FDA Approves Brexucabtagene Autoleucel for Relapsed or Refractory B-Cell Precursor ALL
On October 1, the U.S. Food and Drug Administration (FDA) approved brexucabtagene autoleucel (Tecartus), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). ZUMA-3 Efficacy was evaluated ...
FDA Expands Cetuximab Label With Combination of Encorafenib for Pretreated BRAF V600E Mutation–Positive Metastatic Colorectal Cancer
The U.S. Food and Drug Administration (FDA) has granted approval of a new indication for cetuximab (Erbitux) in combination with encorafenib (Braftovi) for the treatment of adult patients with metastatic colorectal cancer and a BRAF V600E mutation, as detected by an FDA-approved test, after prior...
New Study Aims to Measure Success of Phase III Oncology Trials
New research published by Shen et al in JNCCN—Journal of the National Comprehensive Cancer Network has found that more than 80% of therapies tested in phase III oncology trials did not achieve meaningful clinical benefit in prolonging survival. The researchers analyzed 362 industry-sponsored phase...
Older Adults With Primary CNS Lymphoma: Treatment Opportunities and Challenges
The ASCO Post is pleased to present the Hematology Expert Review, an ongoing feature that quizzes readers on issues in hematology. In this installment, Drs. Abutalib, Desai, and DeAngelis explore the treatment of older patients with primary central nervous system lymphoma (PCNSL), which pose...
Lenvatinib Plus Pembrolizumab for First-Line Treatment of Advanced Renal Cell Carcinoma
On August 10, 2021, the combination of lenvatinib plus pembrolizumab was approved for first-line treatment of adults with advanced renal cell carcinoma.1,2 Supporting Efficacy Data Approval was based on findings from the three-arm, open-label, phase III CLEAR trial (Study 307/KEYNOTE-581;...
Expert Point of View: Gordon Cook, MBChB, PhD and Sagar Lonial, MD
The OPTIMUM/MUKnine1 and FORTE2 updates were discussed at the 2021 ASCO Annual Meeting by Gordon Cook, MBChB, PhD, Clinical Director of the National Institute for Health Research In Vitro Diagnostics Cooperative and the Clinical Trials Unit in Hematology of the University of Leeds, United Kingdom....
Myeloma Trial Updates: Focus on High-Risk Patients and Measurable Residual Disease Negativity
Newly diagnosed patients with multiple myeloma deemed at high risk for disease progression may achieve sustained measurable residual disease (MRD) negativity with newer regimens and transplantation, and this may translate into longer progression-free survival. That’s the key take-away message from...
Nivolumab Plus Chemotherapy Improves Survival in Advanced Gastric and Esophageal Adenocarcinomas: Now to Figure Out the Details in These Heterogeneous Diseases
There is no doubt that subsets of patients with esophageal and gastric cancers benefit from immune checkpoint inhibitor therapy. The complexity lies in identifying the appropriate histology, tumor location, expression of programmed cell death receptors and ligands, mechanism of checkpoint...
ASCO 2021: Roundup of Studies You May Have Missed
As ASCO Annual Meeting attendees know by now, clinicians don’t have to be at McCormick Place to hear practice-changing findings and forward-looking advances in the field of oncology. Interesting content was no exception at the 2021 conference, so in addition to covering the biggest news from the...
Study Examines Efficacy of Sunitinib in Malignant Pheochromocytoma and Paraganglioma
The first randomized study in patients with malignant pheochromocytoma and paraganglioma has found that sunitinib prolongs progression-free survival by more than 5 months. The late-breaking results of the FIRSTMAPPP trial were presented by Eric Baudin, MD, PhD, and colleagues at the European...
Lymphoid Malignancies: What’s Next for Antibody-Drug Conjugates?
Antibody-drug conjugates are improving outcomes of patients with lymphoma, often those who have exhausted treatment options after chimeric antigen receptor (CAR) T-cell therapy. Four available antibody-drug conjugates are in the clinic, with brentuximab vedotin moving into the front-line...
Expert Point of View: Elena Élez, MD, PhD
Invited discussant of the two studies, Elena Élez, MD, PhD, of the Colon Cancer Program, Vall d’Hebron Institute of Oncology, Barcelona, Spain, discussed the challenge of treating BRAF-mutant colorectal cancer and what the new data bring to that effort. Dr. Élez noted: “BRAF V600E–mutant metastatic ...
BRAF-Mutant Colorectal Cancer: Latest Findings for Targeted Treatment
The phase II ANCHOR CRC study, the largest prospective study of BRAF inhibitor–based therapy as first-line treatment of metastatic colorectal cancer, has met its primary endpoint, with 47.8% of patients with metastatic colorectal cancer responding to first-line treatment with encorafenib,...
Ruxolitinib Granted FDA Approval for Chronic Graft-vs-Host Disease
On September 22, the U.S. Food and Drug Administration approved ruxolitinib (Jakafi), a JAK inhibitor, for the treatment of chronic graft-vs-host disease (GVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients aged 12 years and older. REACH3 Efficacy was...
Relacorilant Plus Nab-paclitaxel May Improve Progression-Free Survival in Recurrent Platinum-Resistant Ovarian Cancer
In the first randomized, controlled study to explore the efficacy and safety of relacorilant—a selective glucocorticoid receptor modulator—in combination with nab-paclitaxel compared to nab-paclitaxel alone, the combination improved progression-free survival and showed a favorable safety profile in ...
dd-MVAC vs Gemcitabine/Cisplatin for Muscle-Invasive Bladder Cancer
The randomized phase III controlled GETUG/AFU VESPER V05 trial was designed to compare the efficacy of two perioperative treatment regimens—gemcitabine/cisplatin or dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (dd-MVAC)—in patients with muscle-invasive bladder cancer. The...
Single-Fraction vs Multifraction SABR for Pulmonary Oligometastases: Is There a Difference in Safety or Efficacy?
In the phase II SAFRON II study reported in JAMA Oncology, Shankar Siva, PhD, MBBS, FRANZCR, and colleagues found no significant differences in safety or efficacy between single-fraction vs multifraction stereotactic ablative body radiotherapy (SABR) for the treatment of pulmonary oligometastases. ...
FDA Grants Accelerated Approval to Tisotumab Vedotin-tftv for Recurrent or Metastatic Cervical Cancer
On September 20, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisotumab vedotin-tftv (Tivdak), a tissue factor–directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer who experienced disease progression on ...
DESTINY Breast03: Second-Line Fam-Trastuzumab Deruxtecan-nxki for Metastatic HER2-Positive Breast Cancer
Fam-trastuzumab deruxtecan-nxki (T-DXd) showed statistically significant improvement in progression-free survival vs trastuzumab emtansine (T-DM1) in second-line treatment for HER2-positive unresectable or metastatic breast cancer, according to results from the global phase III DESTINY-Breast03...
KEYNOTE-826: Pembrolizumab Plus Chemotherapy in Advanced Cervical Cancer
The addition of pembrolizumab to chemotherapy prolonged survival in recurrent, persistent, or metastatic cervical cancer, according to results of the KEYNOTE-826 study presented at the European Society for Medical Oncology (ESMO) Congress 2021 by Nicoletta Colombo, MD, and colleagues (Abstract...
Phase III Trial Investigates Extended Adjuvant Endocrine Therapy for Postmenopausal Patients With Breast Cancer
For patients with early-stage hormone receptor–positive breast cancer, extending the duration of letrozole after tamoxifen—for up to 8 years of total endocrine therapy—significantly improved invasive disease–free survival and overall survival over the standard treatment of approximately 5 years of...
Expert Point of View: Carol Aghajanian, MD
“The phase III ENGOT/GCIG study1 proved to be negative, with no advantage seen with the extension of bevacizumab treatment,” said the abstract’s invited discussant, Carol Aghajanian, MD, Chief of the Medical Gynecologic Oncology Service at Memorial Sloan Kettering Cancer Center, New York. Dr....
Bevacizumab in Advanced Ovarian Cancer: Phase III Trial Finds More Is Not Better
In advanced ovarian cancer, the duration of maintenance bevacizumab should remain 15 months, according to the European multicenter phase III ENGOT/GCIG trial. These results were presented during the 2021 ASCO Annual Meeting by Jacobus Pfisterer, MD, PhD, of the AGO Study Group and Gynecologic...
Expert Point of View: Ursula A. Matulonis, MD
Invited discussant Ursula A. Matulonis, MD, Chief of the Division of Gynecologic Oncology at Dana-Farber Cancer Institute, Boston, applauded the improved outcomes favoring lenvatinib/pembrolizumab in the confirmatory KEYNOTE-775 trial. “This represents the start of a new era in endometrial cancer...
Lenvatinib/Pembrolizumab Improves Survival in Advanced Endometrial Cancer in a Phase III Trial
In the first report from the pivotal phase III KEYNOTE-775/Study 309 trial, the combination of lenvatinib, a multikinase inhibitor of VEGFR1, VEGFR2, and VEGFR3 kinases, and the PD-1 inhibitor pembrolizumab significantly improved multiple outcomes compared with standard single-agent chemotherapy in ...
Benefit of Niraparib Maintenance Therapy Extends Beyond First Disease Progression in Recurrent Ovarian Cancer
The PARP (poly [adp-ribose] polymerase) inhibitor niraparib is safe for long-term use and effective as maintenance treatment in patients with platinum-sensitive recurrent ovarian cancer, according to data presented by Ursula A. Matulonis, MD, at the Society of Gynecologic Oncology (SGO) 2021...
Niraparib Plus Bevacizumab Shows Clinical Benefit in Advanced Ovarian Cancer
The addition of niraparib maintenance to first-line platinum-based chemotherapy with bevacizumab demonstrated clinical benefit in patients with advanced ovarian cancer, according to data from the OVARIO study presented by Melissa M. Hardesty, MD, MPH, during the Society of Gynecologic Oncology...
Expert Point of View: Ursula A. Matulonis, MD and Konstantin Zakashansky, MD
Perspectives on ARIEL4 were provided for The ASCO Post by the invited discussant Ursula A. Matulonis, MD, Professor of Medicine, Harvard Medical School, and Chief of Gynecologic Oncology and the Brock Wilson Family Chair at Dana-Farber Cancer Institute, Boston, and Konstantin Zakashansky, MD,...
Phase III ARIEL4 Trial Evaluates Rucaparib’s Benefit in BRCA-Mutated Relapsed Ovarian Cancer
In patients with BRCA-mutated, advanced, relapsed ovarian cancer, treatment with the PARP (poly [ADP-ribose] polymerase) inhibitor rucaparib led to a significant improvement in progression-free survival compared with standard-of-care chemotherapy, according to the results of the international phase ...
Fuzuloparib Maintenance Therapy Improves Progression-Free Survival in Patients With Recurrent Ovarian Cancer
A new poly (ADP-ribose) polymerase (PARP) inhibitor could soon be joining an already crowded treatment landscape in ovarian cancer, according to data presented at the Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women’s Cancer, which was held virtually.1 Results of the phase III...
Expert Point of View: Kunle Odunsi, MD, PhD, and Lilian T. Gien, MD, MSc
Comments on the OUTBACK trial were provided by invited discussant Kunle Odunsi, MD, PhD, Professor of Obstetrics and Gynecology, Dean for Oncology, and Director of the University of Chicago Medicine Comprehensive Cancer Center. Lilian T. Gien, MD, MSc, Associate Professor of Oncology at the...
OUTBACK: No Benefit for Adjuvant Chemotherapy in Locally Advanced Cervical Cancer
In women with locally advanced cervical cancer, adjuvant chemotherapy adds no benefit to standard cisplatin-based chemoradiation, results of the international phase III OUTBACK study have shown,1 as reported at the 2021 ASCO Annual Meeting by Linda R. Mileshkin, MD, Professor of Medical Oncology at ...
Gynecologic Cancers 2020–2021 Almanac
The past year has been a remarkable and noteworthy time with much exciting progress made in gynecologic cancers, despite the underlying presence of the COVID-19 pandemic. Several key studies were presented in 2020–2021 that detailed the results of novel therapies for our patients with cervical,...
Atezolizumab Reduces Risk of Disease Progression in Patients With PD-L1–Expressing Early-Stage NSCLC
Atezolizumab given after chemotherapy to patients with resected stage II to IIIA non–small cell lung cancer (NSCLC) significantly improved disease-free survival compared with best supportive care alone in patients whose tumors expressed PD-L1.1 These results of the global phase III IMpower010 trial ...
Extended Follow-up of PALOMA-3 Supports Survival Benefit of Palbociclib Plus Fulvestrant in Advanced Breast Cancer
An updated analysis of the PALOMA-3 randomized, placebo-controlled trial demonstrated continued superiority for the combination of palbociclib (CDK4/6 inhibitor) plus fulvestrant over fulvestrant plus placebo in women with hormone receptor–positive, HER2-negative advanced breast cancer whose...
ADAPT Trial: ‘Excellent’ Outcomes Reported With Neoadjuvant Dual HER2 Therapy in Breast Cancer
The first overall survival analysis of the WGS-ADAPT HER2+/HR– study, which evaluated neoadjuvant therapy in patients with hormone receptor–negative, HER2-positive disease, showed that treatment with pertuzumab and trastuzumab plus paclitaxel—or with the chemotherapy-free regimen of...
Roundup of Notable Abstracts in Hematologic Malignancies
In addition to covering the biggest news from the meeting in other articles, The ASCO Post brings you these brief news summaries of notable abstracts in multiple myeloma, lymphoma, and leukemia. Maintenance Daratumumab in Multiple Myeloma Part 2 of the CASSIOPEIA trial in 866 patients with newly...
EA1131 Trial: Platinum Not Equal to Capecitabine for Residual Disease in Triple-Negative Breast Cancer
In patients with triple-negative breast cancer who have residual disease after neoadjuvant chemotherapy, adjuvant capecitabine remains the standard of care. In the multicenter randomized noninferiority EA1131 trial, which included primarily basal tumors, noninferiority of adjuvant platinum over...
Fixed-Dose, First-Line Ibrutinib/Venetoclax Combination Achieves Durable Remissions in CLL
The combination of fixed-duration, first-line treatment with ibrutinib plus venetoclax achieved complete responses in more than half of patients with chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL), based on the primary analysis of the fixed-dose cohort of the phase II CAPTIVATE ...
