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lung cancer

Advanced PD-L1–Positive NSCLC: Ivonescimab vs Pembrolizumab

In an interim analysis of a Chinese phase III trial (HARMONi) reported in The Lancet, Xiong et al found that ivonescimab—a bispecific antibody against PD-1 and VEGF—significantly improved progression-free survival vs pembrolizumab in the first-line setting for patients with advanced PD-L1–positive...

lung cancer

Patient With Metastatic NSCLC and Brain Metastasis

This is Part 3 of First-Line Immunotherapy for Metastatic NSCLC: Special Populations and Unmet Needs, a three-part video roundtable series. Scroll down to watch the other videos from this roundtable.   In this video, Drs. Roy Herbst, Charu Aggarwal, and Karen Reckamp discuss the first-line...

lung cancer

HARMONi-2: Ivonescimab Outperforms Pembrolizumab as First-Line Treatment in NSCLC

In a phase III study conducted in China, the bispecific antibody (targeting both PD-1 and the vascular endothelial growth factor [VEGF]) ivonescimab was compared with the PD-1 inhibitor pembrolizumab as first-line treatment of PD-L1–positive advanced non–small cell lung cancer (NSCLC). Ivonescimab ...

lung cancer

‘Encouraging’ Pathologic Responses Achieved With Novel Combination Regimen in Early-Stage NSCLC

In the multiarm phase II NeoCOAST-2 trial, neoadjuvant treatment with datopotamab deruxtecan (Dato-DXd) plus the monoclonal antibody durvalumab and single-agent platinum chemotherapy led to promising rates of pathologic complete and major pathologic responses in patients with early-stage non–small...

lung cancer

‘Encouraging’ Pathologic Responses Achieved With Novel Combination Regimen in Early-Stage NSCLC

In the multiarm phase II NeoCOAST-2 trial, neoadjuvant treatment with datopotamab deruxtecan (Dato-DXd) plus the monoclonal antibody durvalumab and single-agent platinum chemotherapy led to promising rates of pathologic complete and major pathologic responses in patients with early-stage non–small...

lung cancer

HARMONi-2: Ivonescimab Outperforms Pembrolizumab as First-Line Treatment in NSCLC

In a phase III study conducted in China, the bispecific antibody ivonescimab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with the PD-1 inhibitor pembrolizumab as a first-line treatment of PD-L1–positive advanced non–small...

lung cancer

ASCO Issues Updated Guidelines for Stage IV NSCLC With and Without Driver Alterations

ASCO has issued new evidence-based updates to two living guidelines on the treatment of stage IV NSCLC with and without driver alterations.1,2 Updated Recommendations: Stage IV NSCLC With Driver Alterations The most “extensive work” in the updates occurred in the guideline on stage IV NSCLC with...

gastroesophageal cancer
gastrointestinal cancer

Immunotherapy Plus FOLFIRI for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

In a French noncomparative phase II trial (PRODIGE 59-FFCD 1707-DURIGAST) reported in JAMA Oncology, Tougeron et al found limited activity of FOLFIRI (leucovorin, fluorouracil, and irinotecan) plus durvalumab or durvalumab/tremelimumab in the second-line treatment of advanced...

lung cancer

Risk-Adapted Radioimmunotherapy for Locally Advanced PD-L1–Positive NSCLC

In the phase II SPRINT trial reported in the Journal of Clinical Oncology, Ohri et al found that a chemotherapy-sparing regimen of pembrolizumab with risk-adapted radiotherapy was associated with good outcomes in patients with stage III or unresectable stage II non–small cell lung cancer (NSCLC)...

lung cancer

ASTRUM-004: Serplulimab Plus Chemotherapy as First-Line Treatment of Advanced Squamous Non–Small Cell Lung Cancer

A novel treatment approach to squamous non–small cell lung cancer (NSCLC) may improve the prognosis for patients with previously limited treatment options, according to data presented at the International Association for the Study of Lung Cancer 2023 World Conference on Lung Cancer.1 Findings from ...

lung cancer
immunotherapy

Role of TROP-2–Directed Antibody-Drug Conjugates With Immune Checkpoint Inhibitors in Advanced NSCLC

Early-phase trials demonstrate the potential for TROP-2–directed antibody-drug conjugates to enhance the response to immune checkpoint inhibitors in patients with advanced non–small cell lung cancer (NSCLC) without actionable genomic alterations, several investigators reported at the International...

lung cancer

KEYNOTE-671 Trial: Perioperative Pembrolizumab Plus Chemotherapy Improves Outcomes in Stage II and III NSCLC

Neoadjuvant therapy with pembrolizumab plus platinum-based chemotherapy followed by surgery and then adjuvant pembrolizumab led to significantly improved event-free survival in patients with resectable stage II and III non–small cell lung cancer (NSCLC) compared with platinum-based chemotherapy...

lung cancer

ASCO Releases Guideline Updates for Stage IV NSCLC With and Without Driver Alterations

ASCO has updated two living guidelines on the systemic treatment of stage IV non–small cell lung cancer (NSCLC) with and without driver alterations with the inclusion of new evidence-based treatment recommendations.1,2 Among the updates, the guidelines add the recently approved RAS GTPase family...

lung cancer
genomics/genetics

Sotorasib in Pretreated Patients With KRAS G12C–Mutated NSCLC: 2-Year Analysis of CodeBreaK100

In an analysis published in the Journal of Clinical Oncology, Grace K. Dy, MD, and colleagues report 2-year outcomes of the CodeBreaK100 phase I/II trial of sotorasib in previously treated patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer (NSCLC). According...

lung cancer
immunotherapy

Study Finds Neoadjuvant Nivolumab Led to Improved 5-Year Survival Outcomes in Patients With Resectable NSCLC

Lung cancer remains the most commonly diagnosed cancer and the leading cause of cancer-related death worldwide, causing nearly 2 million deaths a year. Although treatment advances in late-stage non–small lung cancer (NSCLC) are extending survival in some patients, breakthroughs for early-stage...

lung cancer
immunotherapy

Addition of Pembrolizumab to Chemotherapy in First-Line Treatment of Metastatic Squamous NSCLC: 5-Year Update of KEYNOTE-407

As reported in the Journal of Clinical Oncology by Silvia Novello, MD, PhD, and colleagues, the 5-year update of the phase III KEYNOTE-407 trial showed continued overall survival and progression-free survival benefit with the addition of pembrolizumab to chemotherapy in the first-line treatment of...

lung cancer

Anti-TIGIT Antibody May Boost the Benefit of Immunotherapy in Stage IV Lung Cancer

In a phase II study of stage IV non–small cell lung cancer (NSCLC), domvanalimab, a novel antibody that blocks T-cell immunoglobulin and ITIM domain (TIGIT), when added to anti–PD-1 zimberelimab immunotherapy resulted in improved response rates and progression-free survival compared with...

lung cancer
immunotherapy

In Stage IV NSCLC, Anti-TIGIT Antibody Boosts Immunotherapy Benefit

In the phase II ARC-7 study, when domvanalimab, a novel antibody that blocks T-cell immunoglobulin and ITIM domain (TIGIT), was added to immunotherapy for patients with stage IV non–small cell lung cancer (NSCLC), the combination resulted in improved response rates and progression-free survival...

lung cancer
genomics/genetics
immunotherapy

First-Line Pembrolizumab vs Chemotherapy in Advanced PD-L1–Positive NSCLC Without EGFR/ALK Alterations

As reported in the Journal of Clinical Oncology by Gilberto de Castro, Jr, MD, PhD, and colleagues, 5-year follow-up of the KEYNOTE-042 trial showed a maintained overall survival benefit with first-line pembrolizumab vs chemotherapy in patients with non–small cell lung cancer (NSCLC) with a PD-L1...

lung cancer
immunotherapy

Adjuvant Pembrolizumab in Patients With Completely Resected Stage IB to IIIA NSCLC

As reported in The Lancet Oncology by O’Brien et al, the second interim analysis of the phase III PEARLS/KEYNOTE-091 trial has shown significantly improved disease-free survival with adjuvant pembrolizumab vs placebo in patients with completely resected stage IB to IIIA non-small cell lung cancer...

gastroesophageal cancer
immunotherapy

Is PD-L1 Expression a Good Predictor of Survival Benefit in Patients With Advanced Gastroesophageal Cancer Treated With Immunotherapy?

In a systematic review and meta-analysis of phase III trials of immune checkpoint inhibitor treatment in patients with advanced gastroesophageal cancer reported in JAMA Oncology, Harry H. Yoon, MD, MS, and colleagues found that PD-L1 expression was the strongest predictor of overall survival...

bladder cancer
immunotherapy

Expert Point of View: Guru P. Sonpavde, MD

Guru P. Sonpavde, MD, Director of the Bladder Cancer Program at Dana-Farber Cancer Institute and a faculty member of Harvard Medical School, Boston, said these follow-up data from CheckMate 274 provide reassurance that the disease-free survival benefit is maintained with adjuvant nivolumab. “We...

gastroesophageal cancer
immunotherapy

PD-1 Inhibition in First-Line Treatment of Advanced Esophageal Squamous Cell Carcinoma: More to Come on New Paradigm

Esophageal cancer is associated with significant morbidity and mortality worldwide, with more than 600,000 new cases and 540,000 deaths in 2020. The squamous cell histology comprises nearly 90% of cases globally, despite its steady decline in the United States over the past 40 years. Historically,...

lung cancer

Study Reports Adjuvant Pembrolizumab Improves Disease-Free Survival in Early-Stage NSCLC

Adjuvant pembrolizumab improves disease-free survival compared with placebo in patients with early-stage non–small cell lung cancer (NSCLC) following complete resection and adjuvant chemotherapy when indicated. These findings from the PEARLS/KEYNOTE-091 trial were reported in a European Society for ...

gastroesophageal cancer

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...

New FDA-Approved Oncology Drugs and Label Updates Between May 8, 2020, and May 8, 2021

Over the past year (May 2020–May 2021), the U.S. Food and Drug Administration (FDA) approved and expanded indications for many drugs related to the treatment of different types of cancers and adverse events. The new approvals and accelerated approvals are listed below. PEMBROLIZUMAB (KEYTRUDA) in...

lung cancer

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...

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. ...

lung cancer
immunotherapy

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...

lung cancer
immunotherapy

CONFIRM Trial Reports Improvement in Survival With Nivolumab in Relapsed Malignant Mesothelioma

For the first time, a treatment has been shown to improve overall survival in heavily pretreated patients with relapsed malignant mesothelioma. In the phase III CONFIRM trial, single-agent nivolumab led to a significant improvement in both overall and progression-free survival, according to...

Expert Point of View: Yun Fan, MD, and Deborah Doroshow, MD, PhD

Invited discussant of KEYNOTE-598,1Yun Fan, MD, Director of Thoracic Tumor Center at Zhejiang Cancer Hospital in Hangzhou, China, suggested that patients with non–small cell lung cancer (NSCLC) with low PD-L1 expression and those with high tumor mutational burden may, in fact, derive the most...

lung cancer

KEYNOTE-598: No Improvement With Addition of Ipilimumab to Pembrolizumab in NSCLC

In the phase III KEYNOTE-598 study, the addition of ipilimumab to pembrolizumab increased toxicity without boosting efficacy as first-line therapy for metastatic non–small cell lung cancer (NSCLC) in patients with high expression of PD-L1. The findings were presented at the International...

lung cancer

FDA Approves Cemiplimab-rwlc for Patients With NSCLC and High PD-L1 Expression

On February 22, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) for the first-line treatment of patients with advanced non–small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score [TPS] > 50%) as determined by an FDA-approved...

lung cancer
immunotherapy

KEYNOTE-598 Trial: Addition of Ipilimumab to Pembrolizumab in Previously Untreated Patients With Metastatic NSCLC and High PD-L1 Expression

As reported in the Journal of Clinical Oncology by Michael Boyer, MBBS, PhD, and colleagues, an interim analysis in the phase III KEYNOTE-598 trial showed no improvement in overall or progression-free survival with the addition of ipilimumab to pembrolizumab in previously untreated patients with...

lung cancer
immunotherapy

Nivolumab Monotherapy Improves Survival in Patients With Relapsed Malignant Mesothelioma

In patients with relapsed malignant mesothelioma, treatment with single-agent nivolumab led to a significant improvement in both overall and progression-free survival in the phase III CONFIRM trial. These findings were presented by Dean A. Fennell, FRCP, PhD, Professor and Chair of Thoracic Medical ...

lung cancer
immunotherapy

Negative Findings in KEYNOTE-598: Ipilimumab Adds No Benefit to Pembrolizumab as First-Line Therapy for NSCLC With High PD-L1 Expression

In the phase III KEYNOTE-598 study, the addition of ipilimumab to pembrolizumab increased toxicity without boosting efficacy as first-line therapy for metastatic non–small cell lung cancer (NSCLC) in patients with high expression of PD-L1, according to research presented at International...

Expert Point of View: Deborah B. Doroshow, MD, PhD

Invited study discussant, Deborah B. Doroshow, MD, PhD, Assistant Professor of Medicine at the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, in New York, noted that the current first-line treatment paradigm for patients with advanced NSCLC and no driver mutation is based on...

breast cancer
immunotherapy

ESMO Breast 2020: Novel Biomarkers May Predict Immunotherapy Benefit in Metastatic Breast Cancer

Two novel biomarkers have been found to correlate with improved outcomes with immunotherapy in metastatic breast cancer and may help to identify the patients most likely to benefit from this treatment, according to exploratory studies reported at the European Society for Medical Oncology (ESMO)...

lung cancer
immunotherapy

Updated Analysis From KEYNOTE-189: Adding Pembrolizumab to Pemetrexed/Platinum for Nonsquamous NSCLC

An updated analysis from the phase III KEYNOTE-189 trial, reported by Shirish Gadgeel, MB, BS, and colleagues in the Journal of Clinical Oncology, indicated that the addition of pembrolizumab to pemetrexed/platinum chemotherapy continues to be associated with progression-free and overall survival...

lung cancer
immunotherapy

Long-Term Outcomes and Retreatment Outcomes With Immunotherapy in PD-L1–Positive Advanced NSCLC

As reported in the Journal of Clinical Oncology by Roy S. Herbst, MD, PhD, and colleagues, long-term follow-up of patients with previously treated advanced programmed cell death ligand 1 (PD-L1)-positive non–small cell lung cancer (NSCLC) in the KEYNOTE-010 trial has shown a continued survival...

lung cancer
immunotherapy

ASCO/CCO Update Guideline for Selecting Systemic Treatment in Stage IV NSCLC Without Driver Mutations

ASCO and Cancer Care Ontario (CCO) have published an update to a joint guideline on systemic therapy for stage IV non–small cell lung cancer (NSCLC) without driver mutations.1 “The treatment of stage IV NSCLC has become increasingly more complicated, and, with the advent of immunotherapy and the...

head and neck cancer
immunotherapy

Immunotherapy for Head/Neck Squamous Cell Carcinoma: Questions Raised by KEYNOTE-048

There is a new first-line treatment option for patients with newly diagnosed, recurrent, or metastatic head and neck squamous cell carcinoma. As reported by Burtness et al in The Lancet, pembrolizumab improved overall survival vs the standard-of-care regimen of cetuximab and platinum-based...

taxotere
opdivo
keytruda

Studies Report Prolonged Long-Term Survival With Immunotherapy vs Chemotherapy in Advanced NSCLC

Longer-term follow-up of patients with advanced non–small cell lung cancer (NSCLC) who are treated with immunotherapy have appreciably extended survival at 5 years, suggesting that for some patients, this disease can be managed as a chronic condition. These findings are based on two presentations ...

lung cancer

Studies Report Prolonged Long-Term Survival With Immunotherapy vs Chemotherapy in Advanced NSCLC

Longer-term follow-up of patients with advanced non–small cell lung cancer (NSCLC) who are treated with immunotherapy have appreciably extended survival at 5 years, suggesting that for some patients, this disease can be managed as a chronic condition. These findings are based on two presentations ...

head and neck cancer
immunotherapy

FDA Approves Pembrolizumab for the First-Line Treatment of Head and Neck Squamous Cell Carcinoma

On June 10, the U.S. Food and Drug Administration (FDA) approved the anti–programmed cell death protein 1 immunotherapy pembrolizumab (Keytruda) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma. Pembrolizumab was approved for...

head and neck cancer
immunotherapy

FDA Approves Pembrolizumab for the First-Line Treatment of Head and Neck Squamous Cell Carcinoma

On June 10, the U.S. Food and Drug Administration (FDA) approved the anti–programmed cell death protein 1 immunotherapy pembrolizumab (Keytruda) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma. Pembrolizumab was...

lung cancer

Pembrolizumab Improves Survival vs Chemotherapy in Previously Untreated Advanced NSCLC With PD-L1 Expression ≥ 1%

As reported in The Lancet by Tony S.K. Mok, MD, of Chinese University of Hong Kong, and colleagues, the KEYNOTE-042 trial has shown an improvement in overall survival with pembrolizumab vs standard chemotherapy in previously untreated patients with locally advanced or metastatic non–small cell lung ...

lung cancer

FDA Expands Pembrolizumab Indication for NSCLC in First-Line Setting

On April 14, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the first-line treatment of patients with stage III non–small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or those with metastatic NSCLC....

lung cancer
immunotherapy

KEYNOTE-042: Pembrolizumab vs Chemotherapy in Previously Untreated Locally Advanced or Metastatic NSCLC With PD-L1 Expression ≥ 1%

As reported in The Lancet by Mok et al, the KEYNOTE-042 trial has shown an improvement in overall survival with pembrolizumab vs standard chemotherapy in previously untreated patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) without a sensitizing EGFR mutation or ...

lung cancer
immunotherapy

FDA Expands Pembrolizumab Indication for NSCLC in First-Line Setting

Today, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the first-line treatment of patients with stage III non–small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or those with metastatic NSCLC....

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