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Showing 301 - 350FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to 5 Months
On January 7, the U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) for the Moderna COVID-19 vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least 5 months for individuals aged 18 years and older....
Bispecific Antibody Mosunetuzumab in Relapsed or Refractory B-Cell Lymphomas
In a phase I study reported in the Journal of Clinical Oncology, L. Elizabeth Budde, MD, PhD, and colleagues found that the CD20-CD3 bispecific antibody mosunetuzumab produced durable responses in patients with relapsed or refractory aggressive and indolent B-cell non-Hodgkin lymphomas....
FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine
On January 3, the U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to expand the use of a single booster dose to include use in individuals aged 12 to 15 years; shorten the time between the completion of primary...
Balstilimab Plus Zalifrelimab for the Second-Line Treatment of Advanced Cervical Cancer
In a phase II trial reported in the Journal of Clinical Oncology, David M. O’Malley, MD, and colleagues found that the PD-1 inhibitor balstilimab and the CTLA-4 inhibitor zalifrelimab—both investigational agents—produced durable responses as second-line treatment for patients with recurrent or...
Sirolimus Protein-Bound Particles for Malignant Perivascular Epithelioid Cell Tumor
On November 22, 2021, sirolimus protein-bound particles for injectable suspension (albumin-bound) was approved for treatment of adults with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor.1 Supporting Efficacy Data Approval was supported by findings in the...
Lynn M. Schuchter, MD, FASCO, Elected ASCO President for 2023–2024 Term
ASCO has elected Lynn M. Schuchter, MD, FASCO, a long-time member and volunteer, to serve as its President beginning in June 2023. Dr. Schuchter will take office as President-Elect immediately after the ASCO Annual Meeting in Chicago in June 2022. Seven new members were also elected to the ASCO...
Composite Biomarker Needed to Predict Benefit of Immunotherapy in Triple-Negative Breast Cancer
Although there is a biomarker that predicts response to the one approved immunotherapy agent for metastatic triple-negative breast cancer, “it is important to note there are no biomarkers of response to neoadjuvant immunotherapy in early-stage triple-negative breast cancer,” Elizabeth A....
POLARIX: Pola-R-CHP vs R-CHOP for Previously Untreated Patients With DLBCL
The POLARIX study found patients with diffuse large B-cell lymphoma (DLBCL) had a significantly higher likelihood of survival without disease progression 2 years after receiving a new drug combination known as pola-R-CHP (polatuzumab vedotin-piiq with rituximab, cyclophosphamide, doxorubicin, and...
Brexucabtagene Autoleucel for Relapsed or Refractory B-Cell Precursor ALL
On October 1, 2021, the CD19-directed chimeric antigen receptor (CAR) T-cell therapy brexucabtagene autoleucel was approved for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1 The product is available only through a restricted program under a Risk Evaluation ...
Patients With Hormone Receptor–Positive Breast Cancer and Emergent ESR1 Mutations May Benefit From Early Switch to Fulvestrant/Palbociclib
Among patients with hormone receptor–positive breast cancer treated with an aromatase inhibitor plus palbociclib, those who displayed a rising ESR1 mutation detected in their blood before disease progression doubled their median progression-free survival following a switch to fulvestrant plus...
Atezolizumab in Adjuvant Therapy for PD-L1–Positive NSCLC
On October 15, 2021, atezolizumab was approved for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non–small cell lung cancer (NSCLC) with PD-L1 expression on ≥ 1% of tumor cells, as determined by a U.S. Food and Drug Administration...
Pembrolizumab for Adjuvant Treatment of Renal Cell Carcinoma
On November 17, 2021, the immunotherapeutic agent pembrolizumab was granted approval for adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or nephrectomy and resection of metastatic lesions.1 Supporting Efficacy Data...
Elacestrant May Improve Outcomes for Postmenopausal Patients With Progressive ER-Positive HER2-Negative Metastatic Breast Cancer
The investigational oral selective estrogen receptor degrader (SERD) elacestrant significantly decreased the risk of death or disease progression and increased progression-free survival compared with standard-of-care endocrine monotherapy in the second- or third-line setting for postmenopausal...
Elacestrant May Improve Outcomes for Postmenopausal Patients With Progressive ER-Positive HER2-Negative Metastatic Breast Cancer
The investigational oral selective estrogen receptor degrader (SERD) elacestrant significantly decreased the risk of death or disease progression and increased progression-free survival compared with standard-of-care endocrine therapy for postmenopausal patients with estrogen receptor...
Pembrolizumab Plus Chemotherapy With or Without Bevacizumab in First-Line Treatment of Advanced Cervical Cancer
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 13, 2021, pembrolizumab in combination with...
FDA Expands Eligibility for COVID-19 Vaccine Boosters
On November 19, the U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals aged 18 years and older after completion of primary vaccination with any ...
Health-Related Quality of Life With Pembrolizumab vs Chemotherapy for Advanced Esophageal Cancer
In a study reported in the Journal of Clinical Oncology, Adenis et al found that health-related quality of life was maintained with both pembrolizumab and chemotherapy in the pivotal phase III KEYNOTE-181 trial, which included patients with advanced esophageal cancer who had received previous...
Clayton Dunklin Pruett, Business Professional, ASCO Member, Dies at Age 86
The delivery of high-quality cancer care relies on a vast network of dedicated experts, some of whom work assiduously behind the scenes, building and modernizing the very architecture on which the cancer community operates. One such person was Clayton Dunklin Pruett, an engineer by training, who...
Cabozantinib for Previously Treated Advanced Differentiated Thyroid Cancer
On September 17, 2021, cabozantinib was approved for adult and pediatric patients aged ≥ 12 years with locally advanced or metastatic differentiated thyroid cancer progressing after VEGFR-targeted therapy and who are ineligible or refractory to radioactive iodine.1 Cabozantinib inhibits the...
Tisotumab Vedotin-tftv in Recurrent or Metastatic Cervical Cancer
On September 20, 2021, tisotumab vedotin-tftv, a tissue factor-directed antibody and microtubule inhibitor conjugate, was granted accelerated approval for the treatment of adults with recurrent or metastatic cervical cancer who have had disease progression on or after chemotherapy.1 Supporting...
Mobocertinib for Platinum-Pretreated Patients With EGFR Exon 20 Insertion–Positive Metastatic NSCLC
In a phase I/II trial reported in JAMA Oncology, Caicun Zhou, PhD, MD, and colleagues found that mobocertinib, a first-in-class oral kinase inhibitor, produced durable responses in platinum-pretreated patients with EGFR exon 20 insertion–positive metastatic non–small cell lung cancer (NSCLC). The...
First-Line Fulvestrant/Palbociclib vs Letrozole/Palbociclib for Endocrine-Sensitive, HR-Positive, HER2-Negative Advanced Breast Cancer
In the phase II PARSIFAL trial reported in JAMA Oncology, Antonio Llombart-Cussac, MD, and colleagues found that the combination of fulvestrant plus palbociclib did not improve progression-free survival vs letrozole plus palbociclib in women with advanced endocrine-sensitive, hormone receptor...
DM-CHOC-PEN May Improve Outcomes for Adolescents and Young Adults With Central Nervous System Tumors
In a phase II clinical trial, the drug 4-demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) improved survival for some adolescent and young adult patients with cancers involving the central nervous system, according to results presented by Morgan et al at the AACR-NCI-EORTC Virtual...
Abiraterone for Castration-Resistant, Androgen Receptor–Expressing Salivary Gland Cancer
In an Italian single-institution phase II trial reported in the Journal of Clinical Oncology, Locati et al found that abiraterone acetate showed activity in patients with androgen deprivation therapy (ADT)-resistant, androgen receptor (AR)-overexpressing salivary gland carcinoma. As stated by the...
FDA Approves Pembrolizumab Combination for the First-Line Treatment of Cervical Cancer
On October 13, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (combined positive score [CPS] ≥ 1), as...
FDA Approves Abemaciclib in Combination With Endocrine Therapy for Early Breast Cancer
On October 12, the U.S. Food and Drug Administration (FDA) approved abemaciclib (Verzenio) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, HER2-negative, node-positive early breast cancer...
Expert Point of View: Yuan Yuan, MD, PhD and Elizabeth Mittendorf, MD, PhD
Yuan Yuan, MD, PhD, a medical oncologist at City of Hope, Duarte, California, weighed in on the KEYNOTE-355 findings. “The study presented by Dr. Rugo on KEYNOTE-355 reconfirms the utility of adding immune checkpoint inhibitors to chemotherapy as front-line treatment for metastatic triple-negative ...
Breast Cancer 2020–2021 Almanac
The past decade has seen an explosion of novel agents for breast cancer across subtypes. Although each new advance improves therapeutic options for patients, it also brings forth a challenging question: Who needs what treatment? Not all cancers are created equally, and similarly not all patients...
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...
PALB2 Added to Secondary Findings List
“It is important to note that a paper on managing individuals with germline variants in PALB2 was published in the same issue of Genetics in Medicine as an article on reporting secondary findings in clinical exome and genome sequencing,”1,2 Douglas R. Stewart, MD, told The ASCO Post. “PALB2 is a...
Enhanced Surveillance and Risk-Reducing Intervention Options for Individuals With PALB2 Variants
PALB2 germline pathogenic variants are associated with a substantially increased risk for breast cancer and a smaller increased risk for pancreatic and ovarian cancers, warranting enhanced surveillance and the option of risk-reducing interventions, according to a global team of cancer genetic...
Ivosidenib vs Placebo for Previously Treated Advanced IDH1-Mutated Cholangiocarcinoma: Final Overall Survival Analysis of the ClarIDHy Trial
As reported in JAMA Oncology by Andrew X. Zhu, MD, PhD, and colleagues, the final overall survival analysis of the pivotal phase III ClarIDHy trial showed prolonged overall survival with ivosidenib vs placebo in previously treated patients with unresectable or metastatic cholangiocarcinoma and an...
Addition of Panitumumab to Fluorouracil/Leucovorin as Maintenance Therapy for RAS Wild-Type Metastatic Colorectal Cancer
In the German phase II PANAMA trial reported in the Journal of Clinical Oncology, Modest et al found that the addition of the monoclonal antibody panitumumab to fluorouracil (5-FU)/leucovorin maintenance therapy improved progression-free survival in patients with RAS wild-type metastatic colorectal ...
Pembrolizumab and Lenvatinib in Advanced Endometrial Carcinoma
On July 21, 2021, pembrolizumab in combination with lenvatinib was granted regular approval for treatment of patients with advanced endometrial carcinoma that is not microsatellite instability–high or mismatch repair–deficient who have disease progression following prior systemic therapy in any...
Paradox Between Cost and Hematopoietic Cell Transplant Rate in Latin America
In this installment of The ASCO Post’s Global Oncology series, Guest Editor Chandrakanth Are, MBBS, MBA, FRCS, FACS, spoke with Gregorio Jaimovich, MD, Director of the Bone Marrow Transplant Program at Favaloro University Hospital in Buenos Aires. Distinguished expert on radiation therapy and bone...
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;...
FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations
The U.S. Food and Drug Administration (FDA) has amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow for the use of a single booster dose to be administered at least 6 months after completion of the primary series in individuals aged 65 years and older;...
COSMIC-021: Cabozantinib Plus Atezolizumab for Advanced Renal Cell Carcinoma
In the phase Ib COSMIC-021 trial reported in the Journal of Clinical Oncology, Sumanta K. Pal, MD, FASCO, and colleagues found that the combination of cabozantinib and atezolizumab produced durable responses in patients with advanced renal cell carcinoma (RCC). Study Details One hundred and two...
Sotorasib: Subgroup Analysis of Phase II Trial Shows Activity With KRAS Inhibitor in Lung Cancer
The KRAS-specific inhibitor sotorasib achieved responses in patients with KRAS G12C–mutated non–small lung cancer (NSCLC) who had experienced disease progression on platinum-based chemotherapy, immunotherapy, or both treatments. The objective response rate was 37.1%, and responses extended to all...
Highlights From the 2021 ASCO Annual Meeting
Despite the ongoing challenges of the COVID-19 pandemic, the practice-changing studies presented at the 2021 ASCO Annual Meeting clarified the continuing momentum in the oncology community to improve the lives of our patients. Immunotherapy demonstrated efficacy in cancers where it had not been...
Expert Point of View: Mary-Ellen Taplin, MD
Invited discussant of the VISION trial, Mary-Ellen Taplin, MD, of Dana-Farber Cancer Institute, Boston, commented on the study, noting that she was a co-investigator of the trial. “Patients with metastatic castration-resistant prostate cancer have a number of treatment options. There are 10...
Amivantamab/Lazertinib Combination May Overcome Osimertinib Resistance in Patients With EGFR-Positive NSCLC
Combination targeting of epidermal growth factor receptor (EGFR) with amivantamab/lazertinib achieved durable responses in more than one-third of chemotherapy-naive patients with EGFR-mutant non–small cell lung cancer (NSCLC) that had progressed on osimertinib, according to a cohort analysis of the ...
Daratumumab and Hyaluronidase-fihj With Pomalidomide Plus Dexamethasone in Multiple Myeloma
On July 9, 2021, daratumumab and hyaluronidase-fihj was approved for use in combination with pomalidomide and dexamethasone (Pd) for treatment of adults with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.1 Supporting...
Pembrolizumab Combined With Trastuzumab and Chemotherapy for HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
On May 5, 2021, pembrolizumab was granted accelerated approval for use in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal...
Pembrolizumab for High-Risk, Early-Stage Triple-Negative Breast Cancer
On July 26, 2021, pembrolizumab was approved for high-risk, early-stage, triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment and continued as adjuvant treatment.1 Pembrolizumab was also granted regular approval in combination with chemotherapy for locally...
Ensartinib Shows Superior Efficacy to Crizotinib in Advanced ALK-Positive NSCLC: eXalt3 Trial
As reported in JAMA Oncology by Leora Horn, MD, MSc, FRCPC, and colleagues, the phase III eXalt3 trial has shown significantly prolonged progression-free survival with ensartinib vs crizotinib in patients with advanced, recurrent, or metastatic anaplastic lymphoma kinase (ALK)-positive non–small...
Phase II Trial Evaluates Oncolytic Coxsackievirus A21 for Unresectable Advanced Melanoma
In a phase II trial reported in the Journal of Clinical Oncology, Robert H.I. Andtbacka, MD, and colleagues found that intratumoral injection of the oncolytic RNA virus Coxsackievirus A21 (V937) was well tolerated and produced responses in some patients with unresectable stage III or stage IV...
Sacituzumab Govitecan-hziy for Locally Advanced or Metastatic Triple-Negative Breast Cancer
On April 7, 2021, sacituzumab govitecan-hziy was granted regular approval for treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.1 Sacituzumab...
Sacituzumab Govitecan-hziy for Locally Advanced or Metastatic Urothelial Cancer
On April 13, 2021, sacituzumab govitecan-hziy was granted accelerated approval to treat patients with locally advanced or metastatic urothelial cancer who had received platinum-containing chemotherapy and either a PD-1 or a PD-L1 inhibitor.1 Supporting Efficacy Data Approval was based on findings...
Comparison of I-131 Metaiodobenzylguanidine–Containing Regimens in Relapsed or Refractory Neuroblastoma
In a phase II New Approaches to Neuroblastoma Therapy (NANT) consortium study reported in the Journal of Clinical Oncology, DuBois et al found that combining the radiotherapeutic I-131 metaiodobenzylguanidine (MIBG) with vorinostat produced a higher response rate in relapsed or refractory...
