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Lung Cancer
Immunotherapy

FDA Approves Cemiplimab-rwlc in Combination With Platinum-Based Chemotherapy for NSCLC

On November 8, the U.S. Food and Drug Administration (FDA) approved the PD-1 inhibitor cemiplimab-rwlc (Libtayo) in combination with platinum-based chemotherapy for adult patients with advanced non–small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations. Study 16113 Efficacy was...

Head and Neck Cancer
Immunotherapy

Indian Trial Explores Addition of Low-Dose Nivolumab to Chemotherapy in Advanced Head and Neck Cancer

In an Indian single-center phase III trial reported in the Journal of Clinical Oncology, Vijay Patil, MBBS, MD, DM, and colleagues found that the addition of low-dose nivolumab to triple metronomic chemotherapy significantly improved overall survival in patients with newly diagnosed or recurrent...

bladder cancer
immunotherapy

Jonathan E. Rosenberg, MD, on Urothelial Cancer: Results From EV-103, Cohort K on Enfortumab Vedotin and Pembrolizumab

Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, discusses recent findings on the safety and antitumor activity of enfortumab vedotin-ejfv given intravenously as monotherapy or in combination with pembrolizumab to previously untreated cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer (Abstract LBA73).

kidney cancer
immunotherapy

Robert J. Motzer, MD, on Renal Cell Carcinoma: New Results With Nivolumab and Ipilimumab

Robert J. Motzer, MD, of Memorial Sloan Kettering Cancer Center, discusses phase III results of the CheckMate 914 trial, which explored the efficacy of adjuvant nivolumab plus ipilimumab vs placebo in the treatment of patients with localized renal cell carcinoma who are at high risk of relapse after nephrectomy (Abstract LBA4).

Multiple Myeloma
Immunotherapy

Ciltacabtagene Autoleucel in Relapsed or Refractory Multiple Myeloma

In a Chinese phase II trial (CARTIFAN-1) reported in the Journal of Clinical Oncology, Mi et al found that the anti–B-cell maturation antigen chimeric antigen receptor (CAR) T-cell therapy ciltacabtagene autoleucel was active in patients with relapsed or refractory multiple myeloma. Study Details...

Skin Cancer
Immunotherapy

Expert Point of View: Alexander M.M. Eggermont, MD; Omid Hamid, MD; and James Larkin, PhD

The results of SWOG S18011 were met with enthusiasm by attendees at the Presidential Symposium of the European Society for Medical Oncology (ESMO) Congress 2022. The ASCO Post captured the thoughts of several melanoma experts, who had somewhat different ideas about the immediate clinical...

Skin Cancer
Immunotherapy

SWOG S1801: Addition of Neoadjuvant Pembrolizumab to Adjuvant Pembrolizumab Yields Benefits in High-Risk Resectable Melanoma

In resectable stage III to IV melanoma, three cycles of neoadjuvant pembrolizumab followed by adjuvant pembrolizumab was significantly more beneficial than adjuvant pembrolizumab alone, based on the results of the phase II SWOG S1801 trial presented in a Presidential Symposium at the European...

Kidney Cancer
Immunotherapy

COSMIC-313: Triplet Therapy Is Active in Renal Cell Carcinoma, but Toxicities Pose a Challenge

The addition of cabozantinib to nivolumab plus ipilimumab prolonged progression-free survival in untreated intermediate-risk patients with advanced renal cell carcinoma (RCC), according to the first results of the phase III COSMIC-313 trial. These findings were presented as a Presidential Symposium ...

Gynecologic Cancers
Immunotherapy

Researchers Discover Differences in Response to Pembrolizumab Among Patients With Endometrial Cancer

Researchers discovered a differential clinical response to pembrolizumab in patients with Lynch-like (mutated) vs methylated microsatellite instability–high endometrial cancer, outlining characteristics of patients who may derive benefit from immune checkpoint blockade antibodies, according to new...

Skin Cancer
Immunotherapy

Neoadjuvant Immunotherapy With Relatlimab and Nivolumab in Stage III Melanoma

The combination of immune checkpoint inhibitors relatlimab and nivolumab for patients with stage III melanoma given before surgery was safe and completely cleared all viable tumor in 57% of patients in a phase II study, according to findings published by Amaria et al in Nature. In addition to...

Gynecologic Cancers
Immunotherapy

Identifying Patients With Ovarian Cancer With Greatest Potential Benefit From First-Line Bevacizumab

In a study reported in the Journal of Clinical Oncology, Benoit You, MD, PhD, and colleagues found that an unfavorable CA-125 elimination rate constant K (KELIM) score, indicating poorer tumor chemosensitivity, was associated with derived benefit from first-line bevacizumab when given with...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

Addition of Bemarituzumab to mFOLFOX in FGFR2b-Selected Gastric or Gastroesophageal Junction Adenocarcinoma

In the phase II FIGHT trial reported in The Lancet Oncology, Zev A. Wainberg, MD, and colleagues found numerically better progression-free survival with the addition of the anti-FGFR2b antibody bemarituzumab to mFOLFOX (modified fluorouracil, leucovorin, and oxaliplatin) in patients with...

Lung Cancer
Immunotherapy

First-Line Toripalimab Plus Chemotherapy in Advanced NSCLC: CHOICE-01

As reported in the Journal of Clinical Oncology by Wang et al, a Chinese phase III trial (CHOICE-01) has shown prolonged progression-free survival with the addition of the anti–PD-1 monoclonal antibody toripalimab to platinum-based chemotherapy in the first-line treatment of patients with advanced...

Skin Cancer
Immunotherapy

Phase II Trial Reports High Response Rates With Neoadjuvant Cemiplimab in Cutaneous Squamous Cell Carcinoma

In an international, multicenter phase II clinical trial, almost two-thirds of patients with stage II to IV cutaneous squamous cell carcinoma had tumors nearly or completely eradicated by neoadjuvant treatment with cemiplimab-rwlc, an agent targeting PD-1. The results were presented at the European ...

Multiple Myeloma
Immunotherapy

FDA Approves Teclistamab-cqyv for Relapsed or Refractory Multiple Myeloma

On October 25, the U.S. Food and Drug Administration (FDA) granted accelerated approval to teclistamab-cqyv (Tecvayli), the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myeloma who have received at least four...

Hepatobiliary Cancer
Immunotherapy

FDA Approves Tremelimumab Plus Durvalumab for Adult Patients With Unresectable HCC

On October 21, the U.S. Food and Drug Administration (FDA) approved tremelimumab (Imjudo) in combination with durvalumab (Imfinzi) for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer. The novel dose and schedule of the...

Immunotherapy
COVID-19

Can Patients With Cancer Treated With Immunotherapy Safely Receive mRNA COVID-19 Vaccines?

New research confirmed the safety of mRNA COVID-19 vaccines in individuals with cancer who are undergoing immunotherapy, according to a novel study published by Widman et al in JNCCN–Journal of the National Comprehensive Cancer Network. The researchers analyzed the frequency of immune-related...

Hematologic Malignancies
Immunotherapy
Symptom Management

Incidence of Neurologic Side Effects From CAR-T Cell Therapy Is Higher in Patients With Hypophosphatemia, Study Finds

Patients with B-cell malignancies who had hypophosphatemia experienced a higher incidence and severity of neurologic side effects from chimeric antigen receptor (CAR) T-cell therapy, according to a study by Nowicki et al published in Cancer Immunology Research. The study results imply that...

Head and Neck Cancer
Immunotherapy

Pembrolizumab With or Without Chemotherapy vs Cetuximab/Chemotherapy in Recurrent or Metastatic Head and Neck Cancer

As reported in the Journal of Clinical Oncology by Kevin Harrington, MD, PhD, and colleagues, updated results of the phase III KEYNOTE-048 trial showed enduring survival benefits with first-line pembrolizumab alone and pembrolizumab/chemotherapy vs cetuximab/chemotherapy in patients with recurrent...

Lung Cancer
Immunotherapy

First-Line Nivolumab/Ipilimumab vs Chemotherapy in Metastatic NSCLC Without EGFR or ALK Alterations: 5-Year Survival

As reported in the Journal of Clinical Oncology by Julie R. Brahmer, MD, MSc, FASCO, and colleagues, a 5-year analysis of the phase III CheckMate 227 trial showed improvement in overall survival with first-line nivolumab/ipilimumab vs platinum-doublet chemotherapy, at ≥ 3 years after cessation of...

Breast Cancer
Immunotherapy

Expert Point of View: Debu Tripathy, MD

Debu Tripathy, MD, Professor and Chair of Breast Medical Oncology at The University of Texas MD Anderson Cancer Center, Houston, shared his thoughts on TROPiCS-02 with The ASCO Post. He said the study is important because it addresses the needs of “a population with limited options, whose...

Breast Cancer
Immunotherapy

TROPiCS-02 Sacituzumab Govitecan Effective in Hormone Receptor–Positive, HER2-Negative Metastatic Breast Cancer

For advanced breast cancer that is hormone receptor–positive and HER2-negative, sacituzumab govitecan-hziy significantly reduced the risk of disease progression by 34% over physician’s choice of treatment, based on the results of the phase III TROPiCS-02 trial.1 The heavily pretreated patients in...

Breast Cancer
Immunotherapy

T-DXd Improves Progression-Free Survival vs T-DM1 in Metastatic HER2-Positive Breast Cancer

As reported in The New England Journal of Medicine by Javier Cortés, MD, PhD, of the International Breast Cancer Center, Barcelona, and colleagues, the phase III DESTINY-Breast03 trial has shown significantly prolonged progression-free survival with fam-trastuzumab deruxtecan-nxki (T-DXd) vs...

Breast Cancer
Immunotherapy

T-DXd Shows Efficacy Against Active Brain Metastases in HER2-Positive Breast Cancer

In the single-center phase II TUXEDO-1 trial of patients with advanced HER2-positive breast cancer, fam-trastuzumab-deruxtecan-nxki (T-DXd) showed efficacy in patients with active brain metastases, yielding intracranial responses in 73.3% of the population and a median progression-free survival of...

Breast Cancer
Immunotherapy

Expert Point of View: Patricia LoRusso, DO, PhD

Invited discussant Patricia LoRusso, DO, PhD, of Yale School of Medicine, said to the assembled audience at the 2022 ASCO Annual Meeting: “I see you are as excited about these data as I am,” after the applause ended following Dr. Modi’s presentation. “I want to thank our colleagues for helping to...

Breast Cancer
Immunotherapy

DESTINY-Breast04 Trial: T-DXd Significantly Improves Survival in Patients With HER2-Low Metastatic Breast Cancer

The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) doubled progression-free survival compared with chemotherapy alone in patients with “HER2-low” metastatic breast cancer—ie, patients with low levels of HER2 expression. The agent also extended overall survival for patients with low ...

Breast Cancer
Immunotherapy

Expert Point of View: Debu Tripathy, MD, and Hope S. Rugo, MD, FASCO

The ASCO Post asked Debu Tripathy, MD, Professor and Chair of Medical Breast Oncology at The University of Texas MD Anderson Cancer Center, Houston, and Hope S. Rugo, MD, FASCO, Professor of Medicine, Director of Breast Oncology and Clinical Trials Education at the University of California San...

Breast Cancer
Immunotherapy

Datopotamab Deruxtecan Shows Activity in Advanced Triple-Negative Breast Cancer

Datopotamab deruxtecan, an antibody-drug conjugate directed against trophoblast cell surface antigen-2 (Trop-2), is showing promise as a treatment for relapsed or refractory advanced triple-negative breast cancer, according to early findings from the phase I TROPION-PanTumor01 trial presented...

Breast Cancer
Immunotherapy

Addition of Pembrolizumab to Chemotherapy Improves Event-Free Survival in Triple-Negative Breast Cancer

As reported in The New England Journal of Medicine by Peter Schmid, MD, PhD, of Barts Cancer Institute, Queen Mary University of London, and colleagues, a preplanned interim analysis of the phase III KEYNOTE-522 trial has shown improved event-free survival with the addition of pembrolizumab to...

Breast Cancer
Immunotherapy

BEGONIA Trial Reports Activity With Datopotamab Deruxtecan Plus Durvalumab in Triple-Negative Breast Cancer

Preliminary results of the basket BEGONIA trial showed that the antibody-drug conjugate datopotamab deruxtecan (Dato-DXd), paired with the immune checkpoint inhibitor durvalumab, has strong activity in advanced or metastatic triple-negative breast cancer among patients not biomarker-selected for...

Breast Cancer
Genomics/Genetics
Immunotherapy

Expert Point of View: Angela DeMichele, MD, MSCE

Angela DeMichele, MD, MSCE, the Alan and Jill Miller Professor in Breast Cancer Excellence at the Perelman School of Medicine of the University of Pennsylvania in Philadelphia, commented on NIMBUS1 for The ASCO Post. She said obtaining information on tumor mutational burden is simple, as it is part ...

Breast Cancer
Genomics/Genetics
Immunotherapy

Dual Checkpoint Inhibitor Therapy Elicits Responses in Highly Mutated Breast Cancer

Patients with advanced HER2-negative metastatic breast cancer and high tumor mutational burden achieved responses—often durable—from treatment with the immunotherapy doublet of nivolumab and ipilimumab, according to results of the phase II NIMBUS trial reported at the 2021 San Antonio Breast Cancer ...

Skin Cancer
Immunotherapy

Mediterranean Diet May Improve Immunotherapy Response Rates and Progression-Free Survival in Advanced Melanoma, New Study Suggests

Following a Mediterranean diet rich in fiber, monounsaturated fatty acids, and polyphenols may be associated with improved immunotherapy response rates and progression-free survival in patients with advanced melanoma, according to a recent study presented at the United European Gastroenterology...

Bladder Cancer
Immunotherapy

Enfortumab Vedotin Plus Pembrolizumab in Cisplatin-Ineligible Patients With Advanced Urothelial Cancer

In a phase Ib/II study reported in the Journal of Clinical Oncology, Christopher J. Hoimes, MD, and colleagues found that first-line enfortumab vedotin-ejfv plus pembrolizumab produced a high response rate and prolonged response durations in cisplatin-ineligible, previously untreated patients with...

Breast Cancer
Immunotherapy

Expert Point of View: Meritxell Bellet Ezquerra, MD, PhD

TROPiCS-02 is a statistically positive trial, with the primary endpoint met and also now with an overall survival gain of 3.2 months,” said the study’s invited discussant Meritxell Bellet Ezquerra, MD, PhD, a senior researcher at the Vall d’Hebron Institute of Oncology, Barcelona. “TROPiCS-02 is...

Breast Cancer
Immunotherapy

TROPiCS-02: Sacituzumab Govitecan Improves Overall Survival in Hormone Receptor–Positive, HER2-Negative Breast Cancer

An overall survival benefit has now emerged for sacituzumab govitecan-hziy in women with previously treated, hormone receptor–positive/HER2-negative, locally recurrent, inoperable or metastatic breast cancer, according to a planned second interim analysis of the phase III TROPiCS-02 trial.1 The...

Lung Cancer
Immunotherapy

Expert Point of View: Mary O’Brien, MD

Formal discussant of the ­KEYNOTE-189 and KEYNOTE-407 trials, Mary O’Brien, MD, Head of the Lung Unit, Royal Marsden Hospital, NHS Foundation Trust, London, found that both studies showed consistent gains in overall and progression-free survival with pembrolizumab/chemotherapy, but she expressed...

Lung Cancer
Immunotherapy

5-Year Follow-up Supports Survival Benefit of Pembrolizumab Plus Chemotherapy in Squamous and Nonsquamous NSCLC

Pembrolizumab (anti–PD-1 therapy) plus chemotherapy continued to demonstrate a survival benefit and durable responses as first-line treatment of metastatic non–small cell lung cancer (NSCLC), according to the results of two phase III trials.1,2 Five-year overall survival was improved in both...

Skin Cancer
Immunotherapy

Expert Point of View: Alexander M.M. Eggermont, MD; Omid Hamid, MD; and James Larkin, PhD

The results of SWOG S18011 were met with enthusiasm by attendees at the Presidential Symposium of the European Society for Medical Oncology (ESMO) Congress 2022. The ASCO Post captured the thoughts of several melanoma experts, who had somewhat different ideas about the immediate clinical...

Skin Cancer
Immunotherapy

SWOG S1801: Addition of Neoadjuvant Pembrolizumab to Adjuvant Pembrolizumab Yields Benefits in High-Risk Resectable Melanoma

In resectable stage III to IV melanoma, three cycles of neoadjuvant pembrolizumab followed by adjuvant pembrolizumab was significantly more beneficial than adjuvant pembrolizumab alone, based on the results of the phase II SWOG S1801 trial presented in a Presidential Symposium at the European...

Kidney Cancer
Immunotherapy

COSMIC-313: Triplet Therapy Is Active in Renal Cell Carcinoma, but Toxicities Pose a Challenge

The addition of cabozantinib to nivolumab plus ipilimumab prolonged progression-free survival in untreated intermediate-risk patients with advanced renal cell carcinoma (RCC), according to the first results of the phase III COSMIC-313 trial. These findings were presented as a Presidential Symposium ...

Lung Cancer
Immunotherapy

Addition of PD-1 Inhibitor Serplulimab to Chemotherapy in the First-Line Treatment of Extensive-Stage SCLC

As reported in JAMA by Cheng et al, an interim analysis of the phase III ASTRUM-005 trial has shown that the addition of the PD-1 inhibitor serplulimab to chemotherapy improved overall survival in the first-line treatment of patients with extensive-stage small cell lung cancer (SCLC). Study ...

Skin Cancer
Immunotherapy

Adjuvant Nivolumab/Ipilimumab vs Nivolumab in Resected Stage IIIB–D or IV Melanoma

As reported in the Journal of Clinical Oncology by Jeffrey S. Weber, MD, PhD, and colleagues, the phase III CheckMate 915 trial showed no improvement in recurrence-free survival with adjuvant nivolumab/ipilimumab vs nivolumab in patients with resected stage IIIB–D or IV melanoma. Study Details In...

Multiple Myeloma
Immunotherapy

GPRC5D-Targeted CAR T-Cell Therapy in Heavily Pretreated Patients With Multiple Myeloma

In a single-institution phase I study reported in The New England Journal of Medicine, Sham Mailankody, MBBS, and colleagues found that chimeric antigen receptor (CAR) T cells targeting G protein–coupled receptor, class C, group 5, member D (GPRC5D) were active in heavily pretreated patients with...

Lung Cancer
Immunotherapy

Real-World Evidence Confirms Survival Benefit of Durvalumab in Locally Advanced Non–Small Cell Lung Cancer

In locally advanced non–small cell lung cancer (NSCLC), immunotherapy consolidation with the PD-L1 inhibitor durvalumab improved overall survival in the PACIFIC trial,1 thus leading to its use after chemoradiotherapy as a standard of care. Real-world evidence of durvalumab’s effect on overall and...

Lung Cancer
Immunotherapy

DART Trial: Concurrent Radiotherapy Plus Durvalumab Active in Older Patients With Locally Advanced Lung Cancer

Interim results of a phase II study have demonstrated the safety and feasibility of treating elderly and frail patients with locally advanced non–small cell lung cancer (NSCLC) with the monoclonal antibody durvalumab during and after radiation therapy, without chemotherapy. The results of a...

leukemia
immunotherapy

Barbara Eichhorst, MD, on CLL: Venetoclax and Obinutuzumab With or Without Ibrutinib vs Chemoimmunotherapy

Barbara Eichhorst, MD, of the German CLL Study Group and the University of Cologne, discusses phase III findings from the GAIA/CLL13 trial, which showed that time-limited treatment with venetoclax, obinutzumab, and ibrutinib or venetoclax plus obinutzumab improved progression-free survival compared with standard chemoimmunotherapy in fit, previously untreated patients with chronic lymphocytic leukemia (Abstract LBA2365).

Immunotherapy

Extended-Interval vs Standard-Interval Dosing of Single-Agent Pembrolizumab

In a retrospective cohort study performed in U.S. veterans reported in JAMA Oncology, Strohbehn et al found that a minority of patients receiving singe-agent pembrolizumab for cancer received the extended-interval dosing of 400 mg every 6 weeks. Analysis of efficacy measured as the time to...

Leukemia
Immunotherapy

Outcomes After Nonresponse and Relapse in Children and Young Adults Receiving Tisagenlecleucel for B-Cell ALL

In a retrospective study reported in the Journal of Clinical Oncology, Schultz et al found poor survival among children and young adults with lack of response to tisagenlecleucel for B-cell acute lymphoblastic leukemia (ALL). Salvage therapy after relapse was capable of inducing responses, but...

Immunotherapy

FDA Approves Biosimilar Bevacizumab-adcd for the Treatment of Six Types of Cancer

On September 28, the U.S. Food and Drug Administration (FDA) approved bevacizumab-adcd (Vegzelma), a biosimilar to bevacizumab (Avastin), for the treatment of six types of cancer: metastatic colorectal cancer; recurrent or metastatic nonsquamous non–small cell lung cancer (NSCLC); recurrent...

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