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Axel S. Merseburger, MD, on Prostate Cancer: New Data From the PRESIDE Trial on Enzalutamide, Docetaxel, and Prednisolone
Axel S. Merseburger, MD, of the University Hospital Schleswig-Holstein, discusses results from a phase IIIb study of chemotherapy-naive patients with metastatic castration-resistant prostate cancer who have been treated with docetaxel plus prednisolone and experienced disease progression on...
Fred Saad, MD, on Prostate Cancer: Results From the PROpel Trial on Olaparib and Abiraterone
Fred Saad, MD, of the University of Montreal Health Centre, discusses phase III findings demonstrating for the first time the clinical benefits of olaparib plus abiraterone in patients with metastatic castration-resistant prostate cancer, irrespective of their homologous recombination repair...
FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments
The U.S. Food and Drug Administration (FDA) has issued three final guidances to industry regarding cancer clinical trials that parallel the goals of President Biden’s recently announced effort to renew and build upon his 2016 Cancer Moonshot initiative. Both endeavors aim to facilitate continued...
FDA Approves Pacritinib for Adult Patients With Myelofibrosis and Thrombocytopenia
On February 28, the U.S. Food and Drug Administration (FDA) approved pacritinib (Vonjo) for the treatment of adults with intermediate- or high-risk primary or secondary (post–polycythemia vera or post–essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. Pacritinib is a...
FDA Approves Ciltacabtagene Autoleucel for Relapsed or Refractory Multiple Myeloma
On February 28, the U.S. Food and Drug Administration (FDA) approved ciltacabtagene autoleucel (Carvykti) for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 ...
Phillip Pifer, MD, PhD, on Head and Neck Squamous Cell Carcinoma: New Data on Focal Adhesion Kinase
Phillip Pifer, MD, PhD, of the UPMC Hillman Cancer Center, discusses findings that suggest focal adhesion kinase is a potentially important target for therapeutic sensitization in patients with mutant TP53 HPV-negative head and neck squamous cell carcinoma.
Biomarker Test May Predict Recurrence of HPV-Driven Oropharyngeal Cancer
A large, multi-institutional study demonstrated that a blood test to detect circulating tumor DNA may accurately predict recurrence of human papillomavirus (HPV)-driven oropharyngeal cancer following treatment. Results also indicated that the biomarker test may detect recurrent disease earlier than ...
Expert Point of View: Amy Tiersten, MD, and Carlos L. Arteaga, MD
Amy Tiersten, MD, Professor of Medicine, Hematology, and Medical Oncology, Icahn School of Medicine at Mount Sinai, and Carlos L. Arteaga, MD, Director of the Simmons Comprehensive Cancer Center and Associate Dean of Oncology at The University of Texas Southwestern Medical Center, Dallas,...
PADA-1 Trial: With Early Identification of ESR1 Mutation, Switch to Fulvestrant in Metastatic Breast Cancer
Switching from an aromatase inhibitor to fulvestrant upon early identification of the ESR1 mutation in plasma—before disease progression—doubled progression-free survival in the phase III PADA-1 trial, presented at the 2021 San Antonio Breast Cancer Symposium.1 “PADA-1 is the first trial to...
EMERALD Trial: Oral Selective Estrogen Receptor Degrader as Second- or Third-Line Therapy for Advanced Breast Cancer
Use of the first investigational oral selective estrogen receptor degrader (SERD) elacestrant significantly reduced the risk of death or disease progression and lengthened progression-free survival compared with standard-of-care endocrine therapy with fulvestrant or an aromatase inhibitor in...
Expert Point of View: Charles Shapiro, MD
Charles Shapiro, MD, Professor of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, commented on the study findings. “MA.32 is a large, randomized placebo-controlled trial of metformin in over 3,600 women with invasive breast cancer. The rationale for...
Metformin Added to Standard Adjuvant Chemotherapy Fails to Improve Outcomes in Early Breast Cancer
The addition of metformin, a drug commonly used to treat type 2 diabetes, to standard adjuvant treatment failed to improve invasive disease–free survival or overall survival for hormone receptor–positive or –negative breast cancer, according to the results of a large landmark trial led by the...
Expert Point of View: Matthew J. Ellis, MB, BChir, PhD, FACP
The final results of the phase III PALLAS trial1 are “deeply disappointing,” said session moderator Matthew J. Ellis, MB, BChir, PhD, FACP, Professor of Medicine and Director of the Lester and Sue Smith Breast Center at Baylor College of Medicine. The results of the final primary analysis of...
Final Analysis of PALLAS Trial: No Benefit of Adjuvant Palbociclib Plus Endocrine Therapy in Early Breast Cancer
The final protocol-defined analysis of the phase III PALLAS trial confirmed the negative results of the second interim analysis, showing no benefit of palbociclib plus endocrine therapy in the adjuvant breast cancer setting. Michael Gnant, MD, of the Medical University of Vienna, reported these...
Expert Point of View: Anne Blaes, MD
Invited discussant Anne Blaes, MD, of the University of Minnesota, Minneapolis, emphasized the main takeaway finding of the combined updated analysis of the SOFT and TEXT trials. “In early-stage estrogen receptor–positive breast cancer, premenopausal women who don’t require chemotherapy do very...
Evidence Supports Ovarian Function Suppression Plus Aromatase Inhibitor in Premenopausal Women With Early Breast Cancer
The benefits of ovarian function suppression were sustained long term for premenopausal women with hormone receptor–positive breast cancer, according to updates from SOFT and TEXT, two randomized, controlled trials, presented at the 2021 San Antonio Breast Cancer Symposium.1 A separate large...
Expert Point of View: David Cescon, MD, PhD
David Cescon, MD, PhD, Clinician Scientist at the Princess Margaret Cancer Centre in Toronto, Canada, was the invited discussant of the two MONALEESA analyses.1,2 He noted that the most recent overall survival analysis, presented at the European Society for Medical Oncology (ESMO) Congress 2021,...
MONALEESA Analyses Show Widespread Benefit for Ribociclib in Hormone Receptor–Positive, HER2-Negative Breast Cancer
Further analyses of the MONALEESA metastatic breast cancer trials have shown that the benefit of ribociclib plus endocrine therapy in the first-line setting extends to most intrinsic molecular subtypes and is consistent across multiple subgroups. The studies were presented at the 2021 San Antonio...
Expert Point of View: Anne Blaes, MD, MS, and Virginia Kaklamani, MD
Commenting on the update of RxPONDER presented at the 2021 San Antonio Breast Cancer Symposium were Anne Blaes, MD, MS, Associate Professor of Hematology/Oncology at the University of Minnesota and Co-Director of the Screening, Prevention, Etiology and Cancer Survivorship Program at the Masonic...
RxPONDER Update Explores Benefit of Chemotherapy in Subgroups
Updated results of the SWOG S1007 RxPONDER trial confirmed the key takeaway from the previous analysis: adjuvant chemotherapy benefits premenopausal women but not postmenopausal women with hormone receptor–positive, HER2-negative disease, one to three positive lymph nodes, and a 21-gene Oncotype DX ...
Expert Point of View: Angela DeMichele, MD, MSCE
Angela DeMichele, MD, MSCE, the Alan and Jill Miller Professor in Breast Cancer Excellence at the Perelman School of Medicine of the University of Pennsylvania in Philadelphia, commented on NIMBUS1 for The ASCO Post. She said obtaining information on tumor mutational burden is simple, as it is...
Dual Checkpoint Inhibitor Therapy Elicits Responses in Highly Mutated Breast Cancer
Patients with advanced HER2-negative metastatic breast cancer and high tumor mutational burden achieved responses—often durable—from treatment with the immunotherapy doublet of nivolumab and ipilimumab, according to the results of the phase II NIMBUS trial reported at the 2021 San Antonio Breast...
Expert Point of View: Hope S. Rugo, MD, FASCO
Invited discussant of the KEYNOTE-355 trial, Hope S. Rugo, MD, FASCO, one of the coauthors of the study, had presented the survival data at the European Society for Medical Oncology (ESMO) Congress 2021.1 The San Antonio presentation was a more in-depth evaluation of survival by different PD-L1...
Identifying Women With Triple-Negative Breast Cancer Who May Benefit From Pembrolizumab Plus Chemotherapy
Results of the phase III randomized KEYNOTE-355 trial showed that the addition of the PD-1 inhibitor pembrolizumab to investigator’s choice of first-line chemotherapy improved progression-free and overall survival in women with metastatic triple-negative breast cancer compared with placebo and...
Expert Point of View: Hope S. Rugo, MD, FASCO
The discussant of KEYNOTE-522 at the 2021 San Antonio Breast Cancer Symposium, Hope S. Rugo, MD, FASCO, Professor of Medicine and Director of Breast Oncology and Clinical Trials Education at the University of California San Francisco Comprehensive Cancer Center, commented: “We are clearly making...
KEYNOTE-522: Sensitivity Analyses Confirm Value of Neoadjuvant Pembrolizumab in Triple-Negative Breast Cancer
Updated results from the pivotal KEYNOTE-522 trial have confirmed the benefit of neoadjuvant therapy with pembrolizumab plus chemotherapy in patients with early triple-negative breast cancer.1 The results were presented at the 2021 San Antonio Breast Cancer Symposium by Peter Schmid, MD, PhD,...
Expert Point of View: Debu Tripathy, MD, and Hope S. Rugo, MD, FASCO
The ASCO Post asked Debu Tripathy, MD, Professor and Chair of Medical Breast Oncology at The University of Texas MD Anderson Cancer Center, Houston, and Hope S. Rugo, MD, FASCO, Professor of Medicine, Director of Breast Oncology and Clinical Trials Education at the University of California San...
Datopotamab Deruxtecan Shows Activity in Advanced Triple-Negative Breast Cancer
Datopotamab deruxtecan, an antibody-drug conjugate directed against trophoblast cell surface antigen-2 (Trop-2), is showing activity as a treatment for relapsed or refractory advanced triple-negative breast cancer, according to early findings from the phase I TROPION-PanTumor01 trial presented...
Clinical Trials Underway for T-DXd in Breast Cancer
The current standard of care for the neoadjuvant treatment of HER2-positive early-stage breast cancer consists of trastuzumab plus pertuzumab and polychemotherapy. But some patients, particularly those with locally advanced or inflammatory disease, still relapse and die. Furthermore, multiagent...
Expert Point of View: Priyanka Sharma, MD
Priyanka Sharma, MD, of the University of Kansas Medical Center in Westwood, the invited discussant of the poster, noted that the DAISY study asked whether HER2-targeted antibody-drug conjugates—in this case, fam-trastuzumab deruxtecan-nxki (T-DXd)—have activity beyond the conventional...
T-DXd Shows Activity in HER2-Low, HER2-Undetectable Breast Cancer
The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) has led to practice changes in previously treated HER2-positive metastatic breast cancer. Most notably, in the DESTINY-Breast03 trial, treatment with T-DXd produced a doubling in 12-month progression-free survival vs...
Expert Point of View: Ciara O’Sullivan, MB, BCh, BAO
Invited discussant Ciara O’Sullivan, MB, BCh, BAO, of Mayo Clinic, Rochester, Minnesota, commented on the DESTINY-Breast03 trial at the 2021 San Antonio Breast Cancer Symposium. “The treatment of HER2-positive disease is an evolving landscape, with eight approved agents. Despite this rapid...
Second-Line T-DXd Improves Progression-Free Survival Across HER2-Positive Metastatic Breast Cancer Subgroups
The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) lengthened progression-free survival and improved the objective response rate compared with the antibody-drug conjugate ado-trastuzumab emtansine (T-DM1) after trastuzumab and taxane therapy in women with HER2-positive metastatic...
Study Identifies New Mutation That May Define Novel Pediatric AML Subtype
A new mutation was identified in 9% of relapsed cases of pediatric acute myeloid leukemia (AML) that may define a new subtype of the disease, according to a study published by Umeda et al in Blood Cancer Discovery. The mutation is a tandem duplication (a series of adjacent repeats of a DNA...
Older Patients With Cancer and High-Risk Geriatric Profiles at Greater Risk for Death and Other Adverse Sequelae of COVID-19
In a large study of 5,671 older adults with COVID-19 and cancer, performed by the COVID-19 and Cancer Consortium (CCC19), the CCC19 geriatric risk index was associated with poorer outcomes, including clinical complications, hospitalization, and mortality. A higher CCC19 geriatric risk index was...
T-Cell Responses May Help Predict Protection Against SARS–CoV-2 Infection in Individuals With and Without Cancer
T-cell responses directed against the receptor-binding domain of the SARS–CoV-2 spike protein were associated with protection from SARS–CoV-2 infection in vaccinated individuals with or without cancer, with lower T-cell responses observed in patients with blood cancers, according to results from a...
Jeffrey Peppercorn, MD, MPH, Named Editor-in-Chief of JCO Oncology Practice
Jeffrey Peppercorn, MD, MPH, has been appointed as the next Editor-in-Chief of the ASCO journal JCO Oncology Practice (JCO OP). The journal publishes impactful information and insights to keep oncology practice current on changes and challenges inherent in delivering equitable, high-quality...
Axel Bex, MD, PhD, on Renal Cell Carcinoma: New Findings From the NeoAvAx Trial on Avelumab and Axitinib
Axel Bex, MD, PhD, of The Netherlands Cancer Institute, discusses an efficacy, safety, and biomarker analysis of neoadjuvant avelumab and axitinib in patients with localized renal cell carcinoma who are at high risk of relapse after nephrectomy (Abstract 289).
Daniel P. Petrylak, MD, on Bladder Cancer: Study EV-103 Cohort H Findings on Enfortumab Vedotin-ejfv
Daniel P. Petrylak, MD, of Yale Cancer Center, discusses new data on the antitumor activity of neoadjuvant treatment with enfortumab vedotin-ejfv monotherapy in patients with muscle-invasive bladder cancer who are not eligible for cisplatin.
Alfredo Berruti, MD, on Adrenocortical Carcinoma: Preliminary Study Results With Adjuvant Mitotane
Alfredo Berruti, MD, of Italy’s University of Brescia, discusses the first study to give adjuvant mitotane to patients with adrenocortical carcinoma, a rare disease with a high risk of relapse after radical surgery. Although theoretically this treatment may be clinically worthwhile, the findings...
Hielke-Martijn de Vries, MD, on Penile Cancer: New Data on Atezolizumab and Radiotherapy
Hielke-Martijn de Vries, MD, of the Netherlands Cancer Institute, discusses phase II findings on the use of atezolizumab with or without radiotherapy for patients with advanced squamous cell carcinoma of the penis. The study was designed to address the poor prognosis for this disease by exploring...
FDA Approves FoundationOne CDx as a Companion Diagnostic for Pembrolizumab to Identify Patients With MSI-H Solid Tumors
On February 21, the U.S. Food and Drug Administration (FDA) approved FoundationOne CDx to be used as a companion diagnostic to identify patients with microsatellite instability–high (MSI-H) status solid tumors who may be appropriate candidates for treatment with pembrolizumab. FoundationOne CDx is...
Partners In Health Founder Paul Farmer, MD, PhD, Dies at 62
Partners In Health announced that its founder, Paul Farmer, MD, PhD, unexpectedly passed away on February 21 in Rwanda from an acute cardiac event. He was 62 years old. Dr. Farmer was the Kolokotrones University Professor and Chair of the Department of Global Health and Social Medicine at Harvard...
Expert Point of View: Joseph Mikhael, MD
The ASCO Post asked Joseph Mikhael, MD, Chief Medical Officer of the International Myeloma Foundation and Professor in the Applied Cancer Research and Drug Discovery Division at the Translational Genomics Research Institute (an affiliate of City of Hope Cancer Center), to comment on the GMMG-HD7...
Isatuximab-Containing Induction Therapy for Multiple Myeloma Increases Measurable Residual Disease Negativity
For the first-line treatment of newly diagnosed multiple myeloma, the percentage of patients achieving measurable residual disease (MRD, previously called minimal residual disease) negativity was significantly greater when the anti-CD38 monoclonal antibody isatuximab was added to a standard...
Expert Point of View: Philip L. McCarthy, MD
The ASCO Post invited myeloma expert Philip L. McCarthy, MD, Director of the Transplant and Cellular Therapy Program at Roswell Park Comprehensive Cancer Center, Buffalo, New York, to comment on the trials evaluating early detection of myeloma at the 2021 American Society of Hematology (ASH) Annual ...
Studies Evaluate Screening for Early Multiple Myeloma
Precursors to multiple myeloma were identified by population screening in two studies reported at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition. The prevalence of monoclonal gammopathies was determined in the PROMISE trial using cutting-edge technology in a high-risk ...
PANTHER: No Significant Benefit for Pevonedistat Plus Azacitidine in Higher-Risk Myelodysplastic Syndrome
The phase III PANTHER trial, which evaluated pevonedistat plus azacitidine vs azacitidine alone in higher-risk myelodysplastic syndromes, chronic myelomonocytic leukemia, and low–blast count acute myeloid leukemia (AML) failed to meet its primary endpoint of event-free survival,1 though lessons...
Mosunetuzumab Meets Primary Endpoint of Phase II Trial in Relapsed or Refractory Follicular Lymphoma
The bispecific antibody mosunetuzumab achieved deep and durable remissions as monotherapy in patients with relapsed or refractory follicular lymphoma, according to the results of a pivotal phase II trial presented at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition.1 In ...
Expert Point of View: Laurie H. Sehn, MD, MPH, and Alex Herrera, MD
Laurie H. Sehn, MD, MPH, Clinical Professor with the BC Cancer Centre for Lymphoid Cancer and University of British Columbia, Vancouver, Canada, and Alex Herrera, MD, Associate Professor in Hematology and Hematopoietic Cell Transplantation at the Beckman Research Institute of City of Hope, Duarte,...
