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Skin Cancer
Immunotherapy

Targeting LAG-3 and PD-1 With Relatlimab and Nivolumab: A New Option Under Study in Advanced Melanoma

Immune checkpoint inhibition has been established as an effective treatment for patients with metastatic melanoma. A novel immunotherapeutic combination—this one targeting the LAG-3 (lymphocyte-activation gene 3) and PD-1 immune checkpoints—delayed time to disease progression significantly more...

kidney cancer
immunotherapy

Brian I. Rini, MD, on RCC: Pembrolizumab Plus Axitinib vs Sunitinib as First-Line Therapy

Brian I. Rini, MD, of Vanderbilt University, discusses findings from KEYNOTE-426, the longest follow-up of a checkpoint inhibitor (pembrolizumab) combined with a VEGF/VEGFR inhibitor (axitinib) for first-line clear cell renal cell carcinoma. The trial results continue to support this combination as a standard of care for patients with previously untreated disease (Abstract 4500).

Kidney Cancer
Immunotherapy

No Survival Difference for Front-Line Combination Regimens in Intermediate- and Poor-Risk Clear Cell RCC: Real-World Outcomes

A large retrospective study of real-world patients with renal cell carcinoma (RCC) showed similar survival outcomes for patients with intermediate- or poor-risk disease regardless of whether they were treated with the combination of axitinib plus pembrolizumab or ipilimumab plus nivolumab. These...

Skin Cancer
Immunotherapy

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...

Kidney Cancer
Immunotherapy

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....

Gastroesophageal Cancer
Immunotherapy

Nivolumab Plus Chemotherapy and Nivolumab Plus Ipilimumab as First-Line Treatment for Patients With Advanced Esophageal Cancer

The first results from the phase III CheckMate 648 study represent significant progress in the treatment of patients with advanced esophageal squamous cell carcinoma. The trial evaluated first-line treatment with nivolumab plus chemotherapy or nivolumab plus ipilimumab in patients with advanced...

Skin Cancer
Immunotherapy

Extended Follow-up of Nivolumab/Ipilimumab for Metastatic Melanoma

In the longest follow-up results from a clinical trial of combination immunotherapy for metastatic melanoma, investigators report that nearly half the patients who received the drugs nivolumab and ipilimumab were alive at a median of 6.5 years after treatment. These long-term results from the...

lung cancer
immunotherapy

Byoung Chul Cho, MD, PhD, on NSCLC: Amivantamab Plus Lazertinib for Treatment of Relapsed Disease

Byoung Chul Cho, MD, PhD, of the Yonsei Cancer Center, discusses study results that showed treatment with the EGFR-MET bispecific antibody amivantamab plus the EGFR inhibitor lazertinib yielded responses in 36% of chemotherapy-naive patients with non–small cell lung cancer whose disease progressed on osimertinib. Genetic biomarkers may be able to identify patients most likely to benefit from the combination regimen (Abstract 9006).

lung cancer
genomics/genetics
immunotherapy

Pasi A. Janne, MD, PhD, on NSCLC: Patritumab Deruxtecan to Target HER3

Pasi A. Janne, MD, PhD, of Dana-Farber Cancer Institute, discusses study findings that show patritumab deruxtecan is effective in patients with EGFR-mutated and inhibitor-resistant non–small cell lung cancer. Dr. Janne also explains why targeting HER3, a mutation expressed in most EGFR-altered cancers, is a beneficial treatment approach (Abstract 9007).

gastroesophageal cancer
immunotherapy

Ian Chau, MD, on Esophageal Squamous Cell Carcinoma: Nivolumab, Ipilimumab, and Chemotherapy for Advanced Disease

Ian Chau, MD, of Royal Marsden NHS Foundation Trust, discusses first results of the CheckMate 648 study, which showed that nivolumab plus chemotherapy and nivolumab plus ipilimumab both demonstrated superior overall survival vs chemotherapy alone in patients with advanced esophageal squamous cell carcinoma. These regimens may represent potential new first-line treatment options (Abstract 4001).

kidney cancer
immunotherapy

Toni K. Choueiri, MD, on Renal Cell Carcinoma: Pembrolizumab vs Placebo in Adjuvant Treatment

Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, discusses phase III results from KEYNOTE-564, which evaluated the safety and efficacy of pembrolizumab in the adjuvant treatment of patients with renal cell carcinoma who have undergone nephrectomy for intermediate-high or high-risk disease or no evidence of disease (Abstract LBA5).

Head and Neck Cancer
Immunotherapy

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...

Leukemia
Immunotherapy

Ponatinib/Blinatumomab Demonstrates High Rates of Complete Molecular Response in Philadelphia Chromosome–Positive ALL

The combination of ponatinib and blinatumomab was found to be safe and highly effective in patients with newly diagnosed or relapsed/refractory Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL). The study—presented by Nicholas J. Short, MD, and colleagues during the 2021 ASCO...

Solid Tumors
Genomics/Genetics
Immunotherapy

Pertuzumab/Trastuzumab Demonstrates Activity in Tissue-Agnostic Trial for Patients With HER2-Positive Tumors

Results from the phase II MyPathway basket trial found that the HER2-targeted therapies pertuzumab and trastuzumab demonstrated durable activity in patients with a wide variety of tumors marked by HER2 amplification or overexpression, although responses were limited in those with KRAS mutations....

Breast Cancer
Immunotherapy

Noninvasive Imaging Biomarker and Pathologic Complete Response to Neoadjuvant Pertuzumab/Trastuzumab in HER2-Positive Breast Cancer

As reported in the Journal of Clinical Oncology by Roisin M. Connolly, MD, and colleagues, updated results of the phase II TBCRC026 trial indicate an association of early F-18 fluorodeoxyglucose positron-emission tomography/computed tomography (F-18 FDG PET/CT) maximum standardized uptake value...

Kidney Cancer
Immunotherapy

Real-World Survival Outcomes With Various Treatment Regimens for Metastatic Renal Cell Carcinoma

In a real-world retrospective propensity-matched cohort study reported in JAMA Network Open, Chakiryan et al found that both first-line immunotherapy and combined treatment with targeted therapy plus immunotherapy were associated with improved overall survival vs targeted therapy alone in patients...

Bladder Cancer
Immunotherapy

Pembrolizumab in BCG-Unresponsive High-Risk Non–Muscle Invasive Bladder Cancer: KEYNOTE-057

As reported in The Lancet Oncology by Arjun V. Balar, MD, and colleagues, the phase II KEYNOTE-057 trial showed that pembrolizumab produced enduring responses in a cohort of patients with high-risk non–muscle invasive bladder cancer unresponsive to bacillus Calmette-Guérin (BCG) who were ineligible ...

Bladder Cancer
Immunotherapy

Does the Addition of Bevacizumab to Gemcitabine/Cisplatin for Metastatic Urothelial Carcinoma Improve Survival?

As reported in the Journal of Clinical Oncology by Jonathan E. Rosenberg, MD, and colleagues, the phase III CALGB 90601/Alliance trial has shown no improvement in overall survival with the addition of bevacizumab to gemcitabine/cisplatin in patients with metastatic urothelial carcinoma.  Study...

Lung Cancer
Immunotherapy

Neoadjuvant Durvalumab With vs Without Stereotactic Body Radiotherapy in Early-Stage NSCLC

In a single-center phase II trial reported in The Lancet Oncology, Nasser K. Altorki, MD, and colleagues found that neoadjuvant durvalumab plus stereotactic body radiotherapy (SBRT) resulted in a markedly higher major pathologic response rate vs durvalumab alone in patients with early-stage...

Lymphoma
Immunotherapy

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...

skin cancer
immunotherapy

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.

Skin Cancer
Immunotherapy

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...

Immunotherapy

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...

Lung Cancer
Immunotherapy

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...

Multiple Myeloma
Immunotherapy

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...

Kidney Cancer
Immunotherapy

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...

Gastrointestinal Cancer
Immunotherapy

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...

Issues in Oncology
Immunotherapy
Breast Cancer
Bladder Cancer
Gastrointestinal Cancer
Hepatobiliary Cancer

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...

Bladder Cancer
Immunotherapy

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...

Skin Cancer
Immunotherapy

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 ...

Gastroesophageal Cancer
Immunotherapy

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 ...

Head and Neck Cancer
Immunotherapy

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, ...

lung cancer
immunotherapy

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).

Skin Cancer
Immunotherapy

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...

Lung Cancer
Immunotherapy

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 ...

Bladder Cancer
Immunotherapy

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...

Skin Cancer
Immunotherapy

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 ...

Skin Cancer
Immunotherapy

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...

Lymphoma
Immunotherapy

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 ...

Breast Cancer
Immunotherapy

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...

Colorectal Cancer
Immunotherapy

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...

Breast Cancer
Immunotherapy

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...

Immunotherapy
Skin Cancer

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....

Lung Cancer
Immunotherapy

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. ...

Breast Cancer
Immunotherapy
Symptom Management

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,...

Breast Cancer
Immunotherapy

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...

Gynecologic Cancers
Immunotherapy

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...

Gynecologic Cancers
Immunotherapy

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...

Breast Cancer
Immunotherapy

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 ...

Kidney Cancer
Gynecologic Cancers
Hepatobiliary Cancer
Immunotherapy

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...

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