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Showing 1651 - 1700Dual Immune Checkpoint Blockade With Nivolumab and Ipilimumab for Treatment of Malignant Pleural Mesothelioma
In recent years, immune checkpoint inhibitors in the treatment of mesothelioma have been a keen area of investigation for this immunogenic solid tumor. With recent publications, principally findings from CheckMate 743 by Baas et al1 (reviewed in this issue of The ASCO Post), combination immune...
Is High Tumor Mutational Burden Predictive of Immune Checkpoint Blockade Efficacy Across All Cancer Types?
In a letter recently published in The New England Journal of Medicine and reviewed in this issue of The ASCO Post, Rousseau and colleagues reported data on the spectrum of benefit from immune checkpoint blockade in hypermutated tumors.1 Indeed, the U.S. Food and Drug Administration (FDA) recently...
Adjuvant Imatinib Therapy Offers Survival Benefit in Patients With Resected GIST, but Team Effort May Be Needed to Reduce Early Discontinuation Rates
Clinical trial data show that adjuvant imatinib improves recurrence-free survival as well as overall survival, when administered for at least 3 years, among patients who undergo a macroscopically complete resection of a primary gastrointestinal stromal tumor (GIST), Chandrajit P. Raut, MD, MSc,...
Adding Targeted Agent to Treatment Shows Significant Benefits in Pediatric Patients With High-Risk Hodgkin Lymphoma
Integrating the antibody-drug conjugate brentuximab vedotin into the front-line treatment of pediatric patients with high-risk Hodgkin lymphoma “facilitated significant reduction in radiation exposure and yielded excellent outcomes,” Monika Metzger, MD, MSc, Director for the Central and South...
Disease-Free Survival Benefit With Adjuvant Immunotherapy in Resectable Esophageal Cancer: Practice-Changing for All Patients?
The CheckMate 577 trial—reported in The New England Journal of Medicine by Kelly et al1 and reviewed in this issue of The ASCO Post—is the first global randomized controlled trial for patients with resectable esophageal cancer that showed a significant disease-free survival benefit for adjuvant...
Cabozantinib With Nivolumab for Metastatic Renal Cell Carcinoma: A New Front-Line Standard
The pace of clinical research in metastatic renal cell carcinoma is faster than ever. Over the past 5 years, we have seen data from six phase III clinical trials evaluating combination strategies with checkpoint inhibitors. The era began with data from CheckMate 214, evaluating nivolumab with...
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 ...
ADAPT: Survival Outcomes After Neoadjuvant Dual HER2 Therapy for HR-Negative, HER2-Positive Breast Cancer
The first overall survival analysis of the WSG-ADAPT HR-/HER2+ study, which evaluated neoadjuvant therapy in patients with hormone receptor (HR)-negative, HER2-positive breast cancer, showed that treatment with pertuzumab and trastuzumab plus paclitaxel—or the chemotherapy-free regimen of...
High-Dose Interferon or Ipilimumab vs Pembrolizumab for High-Risk Resected Melanoma
Patients with high-risk melanoma who had a course of pembrolizumab had longer recurrence-free survival than patients who received either ipilimumab or high-dose interferon after surgery. These findings of a large SWOG Cancer Research Network clinical trial, S1404, were presented by Grossmann et al...
Adjuvant Pembrolizumab Extends Disease-Free Survival in High-Risk Renal Cell Carcinoma
Immunotherapy following surgery significantly improved disease-free survival compared to placebo among patients with high-risk clear cell renal cell carcinoma (RCC), according to results from the international phase III KEYNOTE-564 study presented at the 2021 ASCO Annual Meeting by Toni K....
Novel PSMA-Targeted Radiotherapy Improves Radiographic Progression-Free and Overall Survival in Metastatic Prostate Cancer
Lutetium-177–PSMA-617 (Lu-177–PSMA-617)—an investigational radioligand therapy—significantly improved radiographic progression-free survival and overall survival when added to standard of care compared with standard of care alone for men with metastatic castration-resistant prostate cancer whose...
Sotorasib for KRAS G12C–Mutated NSCLC: Overall Survival and Exploratory Subgroup Analyses
Results from the phase II cohort of the CodeBreaK 100 study showed that treatment with the KRAS G12C inhibitor sotorasib achieved a 37.1% objective response rate and a median overall survival of 12.5 months in previously treated patients with KRAS G12C–mutated non–small cell lung cancer (NSCLC)....
OlympiA: Adjuvant Olaparib Extends Disease-Free Survival in BRCA-Mutated Early-Stage HER2-Negative Breast Cancer
One year of adjuvant therapy with the PARP inhibitor olaparib extended disease-free survival in patients with high-risk, early-stage, HER2-negative breast cancer with BRCA1/2 germline mutations, according to a prespecified interim analysis of the phase III OlympiA trial presented by Andrew Tutt, MB ...
Toripalimab Plus Gemcitabine/Cisplatin Extends Progression-Free Survival in Recurrent or Metastatic Nasopharyngeal Carcinoma: JUPITER-02
According to the results from the phase III JUPITER-02 study, the addition of toripalimab, a humanized IgG4K anti–PD-1 monoclonal antibody, to standard gemcitabine/cisplatin chemotherapy as first-line treatment for patients with advanced nasopharyngeal carcinoma provided superior progression-free...
FDA Grants Accelerated Approval to Infigratinib for Metastatic Cholangiocarcinoma With an FGFR2 Fusion or Rearrangement
On May 28, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the kinase inhibitor infigratinib (Truseltiq) for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or ...
Lisocabtagene Maraleucel for Relapsed or Refractory Large B-Cell Lymphoma
On February 5, 2021, lisocabtagene maraleucel was approved for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from...
Actionable Mutations Identified in Majority of Genome-Sequenced Resected Cholangiocarcinomas
Tumor genomic profiling of resected cholangiocarcinomas may reveal mutations targetable with agents currently being used for other cancers, according to the results of a study presented at the Society of Surgical Oncology (SSO) 2021 International Conference on Surgical Cancer Care.1 Among patients...
American Academy of HIV Medicine Names Leslie McGorman, MPPA, as Director of Public Policy
The American Academy of Human Immunodeficiency Virus (HIV) Medicine recently announced the appointment of Leslie McGorman, MPPA, as its new Director of Public Policy. A seasoned professional in both federal and state government affairs, Ms. McGorman possesses 20 years of health policy experience...
EMPOWER-Lung 1 Trial: New Options, No New Answers
The EMPOWER-Lung 1 trial, recently reported in The Lancet and reviewed in this issue of The ASCO Post, showed an improvement in progression-free and overall survival with cemiplimab-rwlc in patients with advanced non–small cell lung cancer (NSCLC) and high PD-L1 expression (tumor proportion score...
FDA ODAC Meeting Focuses on ‘Dangling’ Accelerated Approvals of Anti–PD-1/PD-L1 Antibodies
In a perspective in The New England Journal of Medicine, Julia A. Beaver, MD, and Richard Pazdur, MD, of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE), discussed issues surrounding “dangling” accelerated approvals of anti–PD-1/PD-L1 antibodies—ie, approvals for...
Pembrolizumab as Long-Term Treatment Option in Relapsed or Refractory Classical Hodgkin Lymphoma
For patients with relapsed or refractory classic Hodgkin lymphoma (HL), salvage chemotherapy followed by autologous hematopoietic stem cell transplant (HSCT) is the standard of care and can induce long-term remissions in at least 60% of patients.1,2 Patients with progression of disease after...
2021 Genitourinary Cancers Symposium: Advancements in the Care of Older Adults With Prostate Cancer
The 2021 Genitourinary (GU) Cancers Symposium was held in a virtual format on February 11–13 and featured the latest developments in the understanding and treatment of genitourinary cancers. The impact of prostate cancer therapies on outcomes in older adults continues to be a growing area of...
NCCN Clinical Practice Guidelines in Oncology: 2021 Updates
In 1996, the National Comprehensive Cancer Network® (NCCN®) published its first set of Clinical Practice Guidelines in Oncology®, covering eight tumor types. Guidelines are now published for more than 60 tumor types and topics. During the NCCN’s 26th Annual Conference, which was held virtually...
FDA Pipeline: Applications Accepted for Marginal Zone Lymphoma and Lung Cancer
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to zanubrutinib in pretreated patients with marginal zone lymphoma, and accepted a biologics license application for sintilimab injection in combination with pemetrexed and platinum chemotherapy for the first-line...
FDA Approves Nivolumab for Resected Esophageal or Gastroesophageal Junction Cancer
On May 20, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) for patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy. CheckMate 577 Efficacy was evaluated in CheckMate ...
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...
Does Adjuvant Atezolizumab Extend Disease-Free Survival in Patients With Resected Early-Stage NSCLC?
Patients with resected early-stage non–small cell lung cancer (NSCLC) who received the PD-L1 inhibitor atezolizumab following cisplatin-based chemotherapy had a 34% reduction in the risk of disease recurrence compared with best supportive care, according to the results from the phase III IMpower010 ...
Single-Agent Pembrolizumab Yields High Response Rates in Patients With Cutaneous Squamous Cell Carcinoma
Single-agent pembrolizumab achieved durable responses and promising survival in patients with locally advanced or recurrent/metastatic cutaneous squamous cell carcinoma, according to the second interim analysis of the phase II KEYNOTE-629 study, which was presented at the virtual American...
Abemaciclib-Associated Adverse Events: Safety Analysis of monarchE
Treatment with abemaciclib, an orally available inhibitor of CDK4/6, has been associated with venous thromboembolic events (VTE), elevated aminotransferases (EAT), and interstitial lung disease (ILD). Although more episodes of VTE, EAT, and ILD were reported in patients receiving abemaciclib plus...
Cardiac Safety, Efficacy of Neoadjuvant Pertuzumab/Trastuzumab for Early-Stage HER2-Positive Breast Cancer
Long-term cardiac safety and efficacy have been confirmed for the combination of pertuzumab plus trastuzumab in patients with early-stage HER2-positive breast cancer, according to the final analysis of the phase II BERENICE trial reported by Chau T. Dang, MD, and colleagues at the ESMO Breast...
Stage IV PD-L1–High Non–Small Cell Lung Cancer: Immunotherapy Alone or With Chemotherapy?
Except in patients with no smoking history, the addition of chemotherapy to immunotherapy does not add benefit as a first-line treatment in patients with stage IV nonsquamous non–small cell lung cancer (NSCLC) and high expression of PD-L1, according to real-world experience. Outcomes from the U.S. ...
Atezolizumab/Carboplatin as Immune Induction in Patients With Metastatic Invasive Lobular Breast Cancer
First results from the phase II GELATO study evaluating atezolizumab plus carboplatin presented at the ESMO Breast Cancer Virtual Congress 2021 demonstrated clinical benefit in patients with metastatic invasive lobular breast cancer, particularly in patients with triple-negative invasive lobular...
Study Finds Ixabepilone Plus Bevacizumab Active in Platinum-Resistant or Recurrent Ovarian Cancer
The addition of bevacizumab to ixabepilone could be a promising treatment strategy for a group of patients with cancer currently lacking therapeutic options, according to data presented during the virtual edition of the Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women’s Cancer.1...
Long-Term Analysis of Short-HER Trial Reported: Shorter Duration of Adjuvant Trastuzumab in HER2-Positive Early Breast Cancer
Long-term analysis of the Short-HER trial showed that 9 weeks of adjuvant trastuzumab conveyed benefits comparable to a 1-year course in patients with early HER2-positive breast cancer deemed to be at low or intermediate risk for disease recurrence. High-risk patients, however, derived considerably ...
Biomarker Analysis of the KAITLIN Trial: No Subgroup Benefits More From T-DM1 Plus Chemotherapy
In the phase III KAITLIN trial, replacing adjuvant taxane and trastuzumab with ado-trastuzumab emtansine (T-DM1) did not result in a significant improvement in invasive disease-free survival in the node-positive or intent-to-treat population, as reported by Harbeck et al at the 2020 ASCO Virtual...
Margetuximab-cmkb: A Novel Agent Overshadowed by an Abundance of Options in HER2-Positive Breast Cancer
It is incredible to reflect upon the scientific advances in the treatment of HER2-positive breast cancer over the past 23 years. Once considered the worst subtype of breast cancer, HER2-positive disease is now associated with the best long-term outcomes in this age of targeted treatments. With a...
Comparing Nivolumab Plus Ipilimumab vs Nivolumab Alone in Resected Stage III to IV Melanoma
The addition of ipilimumab to nivolumab failed to improve outcomes compared with nivolumab alone as adjuvant therapy for resected melanoma, according to the results of the CheckMate 915 trial, presented at the virtual edition of the American Association for Cancer Research (AACR) Annual Meeting...
FDA Approves Nivolumab in Combination With Chemotherapy for Metastatic Gastric Cancer and Esophageal Adenocarcinoma
On April 16, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. CheckMate 649 The...
CHRONOS-3: Addition of Copanlisib to Rituximab Extends Progression-Free Survival in Relapsed Indolent NHL
The combination of the PI3K inhibitor copanlisib plus the monoclonal antibody rituximab reduced the risk of disease progression or death by 48% compared with placebo plus rituximab in patients with relapsed indolent non-Hodgkin lymphoma (NHL), according to the results of the phase III CHRONOS-3...
Tebentafusp Shows Overall Survival Benefit in First-Line Treatment of Metastatic Uveal Melanoma
Treatment with tebentafusp—a novel bispecific fusion protein—reduced the risk of death from metastatic uveal melanoma by half, compared with available treatments, in a phase III study presented at the virtual American Association for Cancer Research (AACR) Annual Meeting 2021.1 This is the first...
Expert Point of View: Ursula Matulonis, MD, and Konstantin Zakashansky, MD
Perspectives on ARIEL4 were provided for The ASCO Post by the invited discussant Ursula 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 by Konstantin Zakashansky, MD,...
Phase III ARIEL4 Confirms 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 results of the international phase III ...
Expert Point of View: Jhanelle E. Gray, MD
Formal discussant of the CheckMate 816 trial, Jhanelle E. Gray, MD, of Moffitt Cancer Center, Tampa, said that both neoadjuvant and adjuvant therapies have been shown to improve overall survival and relapse-free survival in non–small cell lung cancer (NSCLC). “Overall, neoadjuvant outcomes compare...
Squamous Cell Carcinoma of the Head and Neck: Current Status and Future Directions
Although head and neck cancers include multiple histologies and primary sites, squamous cell carcinomas (SCC) originating in the oropharynx, oral cavity, larynx, or hypopharynx are the most common. Today, we recognize several different types of head and neck diseases, primarily those that are human ...
CheckMate 816: Neoadjuvant Nivolumab Plus Chemotherapy Boosts Pathologic Complete Response in Resectable NSCLC
Neoadjuvant chemotherapy with nivolumab plus platinum-doublet chemotherapy significantly improved pathologic complete response rates compared with chemotherapy alone in patients with resectable stage IB to IIIA non–small cell lung cancer (NSCLC), according to the results of the CheckMate 816 study...
Early Triple-Negative Breast Cancer: Are Checkpoint Inhibitors Ready for Neoadjuvant or Adjuvant Use?
Recent clinical trials have been encouraging for the neoadjuvant or adjuvant use of immune checkpoint inhibitors in triple-negative breast cancer, but is this approach ready for the clinic? This question was addressed at PER’s Miami Breast Cancer Conference, held virtually this year, by Adam M....
Karen E. Knudsen, MBA, PhD: The American Cancer Society’s First Female CEO Speaks Out
Karen E. Knudsen, MBA, PhD, of Sidney Kimmel Cancer Center at Jefferson Health, was recently appointed Chief Executive Officer of the American Cancer Society—the first female to head the organization in its 107-year history. Dr. Knudsen talks about the opportunities she sees ahead for the Society...
FDA Grants Accelerated Approval to Pembrolizumab Combination for HER2-Positive Gastric Cancer
On May 5, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) in combination with trastuzumab plus fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic...
More From the FDA ODAC: Votes on Agents for Pretreated Hepatocellular Carcinoma and Gastric Cancer
More news has emerged from this week’s meeting of the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC). The group voted 8 to 0 in favor of continuing the accelerated approval for pembrolizumab in sorafenib-pretreated patients with hepatocellular carcinoma; 6 to 2...
FDA ODAC Votes in Favor of Retaining Accelerated Approval for Bladder Cancer Treatments
Roche has announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to 1 in favor of maintaining the accelerated approval of atezolizumab for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for...
