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...
Evan J. Lipson, MD, on Melanoma: Relatlimab and Nivolumab in First-Line Treatment of Advanced Disease
Evan J. Lipson, MD, of Johns Hopkins University, discusses primary phase III results from the RELATIVITY-047 study, which showed that relatlimab plus nivolumab as a fixed-dose combination may improve progression-free survival compared with nivolumab monotherapy in patients with advanced melanoma. This is the first study to demonstrate a benefit from dual inhibition of the LAG-3 and PD-1 pathways.
Cemiplimab-rwlc for Patients With Locally Advanced Basal Cell Carcinoma After Hedgehog Inhibitor Therapy
As reported in The Lancet Oncology by Stratigos et al, findings in a subgroup of a phase II trial have shown that the PD-1 antibody cemiplimab-rwlc produces enduring responses in patients with locally advanced basal cell carcinoma who had progressive disease on or intolerance to prior hedgehog...
Use of Systemic Therapy at the End of Life in Patients With Cancer: Effect of Approval of Immunotherapies
In a study reported in JCO Oncology Practice, Khaki et al found that although the use of anticancer systemic therapy during the last 30 days of life in patients with cancer has decreased overall since the first approval of a PD-1 immune checkpoint inhibitor, the use of PD-1 or PD-L1 inhibitors...
ORIENT-12 Study: Addition of Sintilimab to Gemcitabine/Platinum in Advanced Squamous NSCLC
Adding sintilimab to a regimen of gemcitabine and platinum demonstrated clinical benefit over gemcitabine and platinum alone as first-line therapy in patients with locally advanced or metastatic squamous non–small cell lung cancer (NSCLC). These results from the ORIENT-12 trial were published by...
Idecabtagene Vicleucel for Relapsed or Refractory Multiple Myeloma
On March 26, 2021, idecabtagene vicleucel was approved for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.1,2 Idecabtagene vicleucel is...
First-Line Nivolumab Plus Cabozantinib Improves Progression-Free and Overall Survival vs Sunitinib in Advanced Renal Cell Carcinoma
As reported in The New England Journal of Medicine by Toni K. Choueiri, MD, of Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, and colleagues, the phase III CheckMate 9ER trial has shown that the combination of nivolumab and cabozantinib improved progression-free survival and...
Fam-trastuzumab Deruxtecan-nxki for Trastuzumab-Pretreated Advanced HER2-Positive Gastric Adenocarcinoma
On January 15, 2021, the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki was approved for treatment of adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma who have received a prior trastuzumab-based regimen.1,2 Supporting Efficacy Data...
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...
Enfortumab Vedotin-ejfv After PD-1 or PD-L1 Inhibitor Therapy for Cisplatin-Ineligible Patients With Advanced Urothelial Carcinoma
As reported in The Lancet Oncology by Evan Y. Yu, MD, and colleagues, findings in a cohort of the phase II EV-201 study showed a high response rate with the nectin-4–directed antibody-drug conjugate enfortumab vedotin-ejfv in cisplatin-ineligible patients with advanced or metastatic urothelial...
Ipilimumab Plus Anti–PD-1 Therapy vs Ipilimumab Alone for Patients With Advanced Melanoma Resistant to Anti–PD-1/PD-L1 Monotherapy
In a retrospective cohort study reported in The Lancet Oncology, da Silva et al found that better outcomes were achieved with the combination of an anti–PD-1 agent plus ipilimumab vs ipilimumab alone in patients with advanced melanoma who were resistant to prior anti–PD-1 or anti–PD-L1 ...
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 ...
Pembrolizumab Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer
In a cohort of a phase II trial reported in The Lancet Oncology, Assuntina G. Sacco, MD, and colleagues found that the combination of pembrolizumab and cetuximab produced durable responses in patients with recurrent or metastatic head and neck squamous cell carcinoma who had received no prior PD-1, ...
Heather A. Wakelee, MD, on NSCLC: Atezolizumab vs Best Supportive Care After Chemotherapy
Heather A. Wakelee, MD, of Stanford University Medical Center, discusses the primary disease-free survival results of IMpower010, a phase III study that compared adjuvant atezolizumab vs best supportive care after adjuvant chemotherapy in patients with early-stage resected non–small cell lung cancer (Abstract 8500).
First-Line Nivolumab/Relatlimab vs Nivolumab Alone for Advanced Melanoma
Treatment with the anti–PD-1 therapy nivolumab plus the LAG-3–blocking antibody relatlimab extended time to disease progression for patients with previously untreated, unresectable, or metastatic melanoma. Findings from the RELATIVITY-047 trial were presented by Evan J. Lipson, MD, and colleagues...
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 ...
Sacituzumab Govitecan-hziy for Patients With Pretreated Metastatic Urothelial Carcinoma
In a cohort of the phase II TROPHY-U-01 trial reported in the Journal of Clinical Oncology, Scott T. Tagawa, MD, MS, and colleagues found that the antibody-drug conjugate sacituzumab govitecan-hziy produced responses in patients with metastatic urothelial carcinoma progressing after platinum-based...
Expert Point of View: Stefania Scala, MD
Formal discussant Stefania Scala, MD, of the Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, was impressed by the findings of KEYNOTE-629. “The second interim analysis for the locally advanced disease cohort and updated data for the recurrent/metastatic disease cohort of KEYNOTE-629 had ...
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...
Loncastuximab Tesirine-lpyl for Heavily Pretreated Patients With Relapsed or Refractory DLBCL: LOTIS-2
As reported in The Lancet Oncology by Caimi et al, the phase II LOTIS-2 trial has shown that the CD19-directed antibody–alkylating drug conjugate loncastuximab tesirine-lpyl produced durable responses in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study supported ...
Pertuzumab/High-Dose Trastuzumab in Patients With HER2-Positive Metastatic Breast Cancer and Progressive Brain Metastases
In the phase II PATRICIA trial reported in the Journal of Clinical Oncology, Nancy U. Lin, MD, and colleagues found that pertuzumab plus high-dose trastuzumab produced central nervous system (CNS) objective responses and clinical benefit in 68% of patients with HER2-positive metastatic breast...
Trastuzumab Deruxtecan-nxki in HER2-Positive Metastatic Colorectal Cancer: DESTINY-CRC01
In the phase II DESTINY-CRC01 trial reported in The Lancet Oncology, Salvatore Siena, MD, and colleagues found that trastuzumab deruxtecan-nxki produced durable responses in patients with previously treated HER2-positive metastatic colorectal cancer. Study Details In the trial, 78 patients from...
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...
Pembrolizumab/Ipilimumab After Disease Progression on PD-1/PD-L1 Inhibitor Therapy in Advanced Melanoma
In a phase II trial reported in the Journal of Clinical Oncology, Olson et al found that pembrolizumab plus low-dose ipilimumab produced durable responses in patients with advanced melanoma whose disease had progressed on immediate prior PD-1 or PD-L1 inhibitor therapy. Study Details In the U.S....
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. ...
Incidence of Interstitial Lung Disease Related to Trastuzumab Deruxtecan-nxki in Patients With HER2-Positive Metastatic Breast Cancer
Drug-related interstitial lung disease occurred in less than 16% of patients with HER2-positive metastatic breast cancer following treatment with trastuzumab deruxtecan-nxki (T-DXd) at the approved dose of 5.4 mg/kg. In addition, the majority of these cases were classified as grade 1 or 2,...
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...
Expert Point of View: Thomas Herzog, MD
Discussant of this phase II study, Thomas Herzog, MD, Deputy Director of the University of Cincinnati Cancer Center and Professor of Obstetrics and Gynecology at the UC College of Medicine, called the results “very exciting.” “The 33% response rate with the combination of ixabepilone plus...
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 ...
FDA Pipeline: Priority Reviews in Kidney and Endometrial Cancers, Cholangiocarcinoma
Recently, the U.S. Food and Drug Administration (FDA) has granted Priority Review to the combination of pembrolizumab and lenvatinib for the treatment of both advanced renal cell carcinoma (RCC) and endometrial carcinoma. The FDA also granted Priority Review to ivosidenib for the treatment of...
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...
Margetuximab-cmkb Plus Chemotherapy Prolongs Progression-Free Survival in Heavily Pretreated HER2-Positive Breast Cancer
As reported in JAMA Oncology by Hope S. Rugo, MD, of the University of California San Francisco Helen Diller Family Comprehensive Cancer Center, and colleagues, the phase III SOPHIA trial has shown significantly prolonged progression-free survival with margetuximab-cmkb plus chemotherapy vs...
Study Finds Adjuvant Immunotherapy of Benefit to Patients With Stage IIB/C Melanoma
A significant survival advantage accrued to patients with stage IIB and IIC cutaneous melanoma who received adjuvant immunotherapy, a large retrospective cohort study reported at the Society of Surgical Oncology (SSO) 2021 International Conference on Surgical Cancer Care.1 The 3-year overall...
Cemiplimab-rwlc for First-Line Treatment of NSCLC With High PD-L1 Expression
On February 22, 2021, cemiplimab-rwlc was approved for first-line treatment of patients with advanced non–small cell lung cancer (NSCLC; locally advanced who are not candidates for surgical resection or definitive chemoradiation therapy or metastatic) whose tumors have high PD-L1 expression (tumor...
Expert Point of View: Alexander Eggermont, MD, PhD
Formal discussant of CheckMate 915, Alexander Eggermont, MD, PhD, Chief Scientific Officer at the Princess Máxima Center for Pediatric Oncology, Utrecht, Netherlands, suggested that the lower doses of ipilimumab used in the current study may explain the lack of effect on relapse-free survival. The...
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...
Bispecific Antibody Platform: Early Data in Relapsed and Refractory Myeloma
“There was never a night or a problem that could defeat sunrise or hope.” —Bernard Williams To complement The ASCO Post’s continued comprehensive coverage of the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting...
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...
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...
IMagyn050 Trial: Addition of Atezolizumab to Bevacizumab and Chemotherapy for Newly Diagnosed Stage III or IV Ovarian Cancer
As reported in the Journal of Clinical Oncology by Kathleen N. Moore, MD, and colleagues, the phase III IMagyn050/GOG 3015/ENGOT-OV39 trial has shown that the addition of atezolizumab to bevacizumab and chemotherapy did not significantly improve progression-free survival in patients with newly...
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...
FDA Pipeline: Priority Reviews of Treatments for Bladder and Lung Cancers
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review designation to treatments for surgically resected, high-risk, muscle-invasive urothelial carcinoma and epidermal growth factor receptor exon 20 insertion mutation–positive metastatic non–small cell lung cancer (NSCLC)....
Brentuximab Vedotin Plus Chemotherapy in Newly Diagnosed Early-Stage Unfavorable-Risk Hodgkin Lymphoma
In a pilot study reported in the Journal of Clinical Oncology, Kumar et al found that the combination of brentuximab vedotin with AVD (doxorubicin, vinblastine, and dacarbazine) was highly active in patients with newly diagnosed, early-stage, unfavorable-risk Hodgkin lymphoma and may permit the...
Antiviral T Cells for BK Virus–Associated Hemorrhagic Cystitis
A phase II trial has found found that BK virus (BKV)-specific T cells from healthy donors were safe and effective as an off-the-shelf therapy for BKV-associated hemorrhagic cystitis, a painful complication that is common after allogeneic stem cell transplants for patients with leukemia or lymphoma. ...
First-Line Immune Checkpoint Inhibitor Monotherapy vs Chemoimmunotherapy in Advanced NSCLC According to KRAS Variant Status
In a study reported in a research letter in JAMA Oncology, Sun et al found that first-line immune checkpoint inhibitor monotherapy was associated with better overall survival among patients with advanced non–small cell lung cancer (NSCLC) with PD-L1 expression ≥ 50% and KRAS variant vs KRAS...
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...
Five-Year Efficacy Outcomes With Pembrolizumab vs Chemotherapy in Metastatic NSCLC With PD-L1 Tumor Proportion Score of at Least 50%
As reported by Martin Reck, MD, PhD, and colleagues in the Journal of Clinical Oncology, the 5-year follow-up of the pivotal phase III KEYNOTE-024 trial shows maintained overall survival benefit in patients treated with pembrolizumab vs chemotherapy—despite substantial crossover to the...
Adjuvant Trastuzumab With or Without Chemotherapy in Older Patients With HER2-Positive Breast Cancer: Health-Related Quality of Life
In an analysis from the Japanese RESPECT trial reported in the Journal of Clinical Oncology, Taira et al found that adjuvant trastuzumab monotherapy was associated with better health-related quality of life (QoL) vs trastuzumab plus standard chemotherapy for at least 12 months in women aged 70 to...
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...
