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Lymphoma
Immunotherapy

FDA Approves Lisocabtagene Maraleucel for Patients With Relapsed or Refractory Large B-Cell Lymphoma

On February 5, 2021, the U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel (Breyanzi) 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...

lung cancer
immunotherapy

Fred R. Hirsch, MD, PhD, on Lung Cancer: Survival and Tumor Mutation Burden

Fred R. Hirsch, MD, PhD, of Mount Sinai Medical Center, discusses Lung-MAP studies in which a higher tumor mutation burden determined by next-generation sequencing was linked to overall and progression-free survival across two immunotherapy trials, and was independent of PD-L1 status (Abstract OA01.04).

Lung Cancer
Immunotherapy

HIC Assays May Aid in Predicting Response to Immunotherapy Among Patients With NSCLC

Using a host immune classifier (HIC) test for patients with non–small cell lung cancer (NSCLC) may provide better predictors of treatment response and improve outcomes, according to research presented by Akerley et al at the International Association for the Study of Lung Cancer (IASLC) 2020 World...

Lymphoma
COVID-19
Immunotherapy

Patients With Lymphoma Receiving B-Cell–Depleting Therapies May Be at Greater Risk for Persistent COVID-19 Infection

B-cell–depleting immunotherapy may cause B-cell aplasia and impair the body’s immune response. A retrospective, multicentric French study of patients with lymphoma and persistent COVID-19 infection has found that those treated with B-cell–depleting therapies within the previous 12 months had nearly ...

solid tumors
immunotherapy

Prasad S. Adusumilli, MD, on Cell Therapy for Solid Tumors

Prasad S. Adusumilli, MD, of Memorial Sloan Kettering Cancer Center, discusses ongoing CAR T-cell therapy clinical trials for solid tumors, the key determinants of success for developing this treatment, and some study results to date (Abstract PL03.05).

Breast Cancer
Immunotherapy

Margetuximab-cmkb vs Trastuzumab in Heavily Pretreated Patients With HER2-Positive Breast Cancer: SOPHIA Trial

As reported in JAMA Oncology by Hope S. Rugo, MD, and colleagues, the phase III SOPHIA trial has shown significantly prolonged progression-free survival with margetuximab-cmkb plus chemotherapy vs trastuzumab plus chemotherapy in patients with HER2-positive breast cancer who experienced disease...

lung cancer
immunotherapy

Dean Fennell, FRCP, PhD, on Mesothelioma: Nivolumab vs Placebo in Relapsed Disease

Dean Fennell, FRCP, PhD, of the University of Leicester, discusses phase III results from the CONFIRM trial, which sought a standard immunotherapy treatment to improve overall survival for patients with mesothelioma who have relapsed after taking pemetrexed and cisplatin. Globally, the incidence of mesothelioma is on the rise; in the United Kingdom alone, it has gone up nearly 500% since the 1970s (Abstract PS01.11).

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

LCMC3 Trial: Neoadjuvant Atezolizumab for Patients With Stage IB to IIIB Resectable Lung Cancer

Neoadjuvant treatment with single-agent atezolizumab for patients with stage IB to IIIB lung cancer resulted in a major pathologic response rate of 21% and pathologic complete response rate of 7% in the primary analysis of the Lung Cancer Mutation Consortium 3 (LCMC3) study. The findings were...

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...

Lung Cancer
Immunotherapy

CheckMate 9LA Trial: First-Line Nivolumab/Ipilimumab Plus Chemotherapy vs Chemotherapy Alone in Stage IV or Recurrent NSCLC

As reported in The Lancet Oncology by Luis Paz-Ares, MD, and colleagues, the phase III CheckMate 9LA trial has shown improved overall survival with first-line nivolumab/ipilimumab plus two cycles of chemotherapy vs four cycles of chemotherapy alone in patients with stage IV or recurrent non–small...

Immunotherapy
Gastroesophageal Cancer
Gastrointestinal Cancer
Colorectal Cancer
Bladder Cancer
Skin Cancer
Sarcoma
Hepatobiliary Cancer

FDA Pipeline: Priority Reviews for Immunotherapies in Gastric Cancers, Anal Cancer

The U.S. Food and Drug Administration (FDA) recently granted Priority Review to nivolumab as either adjuvant or first-line therapy in several types of gastric cancers, as well as to a novel PD-1 inhibitor for locally advanced or metastatic squamous cell carcinoma of the anal canal. The FDA also...

Hematologic Malignancies
Immunotherapy

Early Research Explores Relationship Between CD58 Loss and Resistance to CAR T-Cell Therapies

Engineering chimeric antigen receptor (CAR) T cells to overcome CD58 loss may be a way to boost responses in patients with diffuse large B-cell lymphoma (DLBCL) who do not respond to treatment with axicabtagene ciloleucel and other CAR T-cell therapies, according to an experimental study presented...

Colorectal Cancer
Immunotherapy

Addition of Vemurafenib to Irinotecan/Cetuximab in Previously Treated Patients With BRAF V600E–Mutant Metastatic Colorectal Cancer

In a phase II trial (SWOG S1406) reported in the Journal of Clinical Oncology, Scott Kopetz, MD, PhD, and colleagues found that the addition of vemurafenib to irinotecan and cetuximab significantly improved progression-free survival in previously treated patients with BRAF V600E–mutant metastatic...

Leukemia
Immunotherapy
Symptom Management

Preemptive Tocilizumab for Cytokine-Release Syndrome in Pediatric Patients With B-Cell ALL Receiving CAR T-Cell Therapy

In a single-institution study reported in the Journal of Clinical Oncology, Kadauke et al found that risk-adapted tocilizumab reduced the expected incidence of grade 4 cytokine-release syndrome in pediatric patients receiving CD19-directed chimeric antigen receptor (CAR) T-cell...

Multiple Myeloma
Immunotherapy

Expert Point of View: Sagar Lonial, MD, and Adam D. Cohen, MD

The studies of ALLO-715 “off-the-shelf” CAR T-cell therapy and bb21217 impressed two experts in the field. Sagar Lonial, MD, the Anne and Bernard Gray Family Chair in Cancer, Chair and Professor of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, and Adam D. Cohen, MD, ...

Multiple Myeloma
Immunotherapy

Novel Anti-BCMA CAR T-Cell Therapies Show Activity in Myeloma

In the treatment of relapsed or refractory multiple myeloma, chimeric antigen receptor (CAR) T-cell therapies with unique characteristics, still targeting B-cell maturation antigen (BCMA), are looking promising. At the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition,...

Kidney Cancer
Immunotherapy

FDA Approves Nivolumab Plus Cabozantinib for Advanced Renal Cell Carcinoma

On January 22, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo) and cabozantinib (Cabometyx) as first-line treatment for patients with advanced renal cell carcinoma. CheckMate 9ER Efficacy was evaluated in CheckMate 9ER, a randomized, open-label trial in...

Skin Cancer
Immunotherapy

First-Line Nivolumab/Ipilimumab in Metastatic Uveal Melanoma

In a Spanish phase II trial reported in the Journal of Clinical Oncology, Piulats et al found that nivolumab/ipilimumab produced a “modest” improvement in overall survival vs historical rates achieved with chemotherapy as first-line treatment for patients with metastatic uveal melanoma ineligible...

solid tumors
immunotherapy

Thierry André, MD, on Mismatch Repair–Deficient Solid Cancers: Safety and Efficacy of Dostarlimab

Thierry André, MD, of Hôpital Saint-Antoine, discusses results from the GARNET study, which showed that dostarlimab, an anti–PD-1 antibody, demonstrated durable antitumor activity in patients with mismatch repair–deficient colorectal and noncolorectal solid tumors. No new safety signals were detected, and most treatment-related adverse events were of a low grade (Abstract 9).

hepatobiliary cancer
immunotherapy

Richard S. Finn, MD, on HCC: Atezolizumab Plus Bevacizumab vs Sorafenib

Richard S. Finn, MD, of the UCLA Medical Center, discusses updated results from the IMbrave 150 study, which showed atezolizumab plus bevacizumab provides the longest overall survival seen in a front-line phase III study in advanced hepatocellular carcinoma, confirming this combination as the standard of care for patients with previously untreated, unresectable disease (Abstract 267).

Multiple Myeloma
Immunotherapy

Belantamab Mafodotin-blmf in Multiple Myeloma: Number of Prior Treatments No Hindrance to Efficacy

A post hoc analysis of the phase II DREAMM-2 trial showed single-agent belantamab mafodotin-blmf to be efficacious and tolerable in patients with relapsed  or refractory multiple myeloma treated with at least three prior therapies, investigators reported at the 2020 American Society of Hematology...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

Bemarituzumab Plus Chemotherapy Improves Outcomes in Advanced Gastric/Gastroesophageal Junction Cancer

Gastric cancer has a new target: fibroblast growth factor receptor 2b (FGFR2b). Targeting FGFR2b with bemarituzumab plus chemotherapy led to clinically meaningful and statistically significant improvements in progression-free survival, overall survival, and response rates in the randomized phase II ...

colorectal cancer
immunotherapy

Kai-Keen Shiu, MD, PhD, on Colorectal Cancer: Pembrolizumab vs Chemotherapy for Microsatellite Instability–High Disease

Kai-Keen Shiu, MD, PhD, of the University College Hospital NHS Foundation Trust - London, discusses an interim analysis of PFS 2 results (defined as time from random assignment to progression on the next line of therapy or death) from the phase III KEYNOTE-177 trial. This study has already shown that first-line pembrolizumab provides a clinically meaningful and statistically significant improvement in PFS compared with chemotherapy in patients with microsatellite instability–high metastatic colorectal cancer (Abstract 6).

gastroesophageal cancer
immunotherapy

Wasat Mansoor, MBChB, PhD, on Esophageal Cancer: Quality of Life With Pembrolizumab and Chemotherapy

Wasat Mansoor, MBChB, PhD, of The Christie NHS Foundation Trust, discusses phase III results from the KEYNOTE-590 trial, which showed no deterioration in health-related quality of life when pembrolizumab was added to chemotherapy in patients with metastatic and unresectable esophageal cancers (Abstract 168).

CNS Cancers
Immunotherapy

Patients With Recurrent Glioblastoma and a Very Low Mutation Burden May Respond Best to Immunotherapy

A new study has found that patients with recurrent glioblastoma and a very low tumor mutation burden are more responsive to immunotherapies than similar tumors with an abundance of mutations. These findings, published by Gromeier et al in Nature Communications, could serve as a predictive biomarker ...

Hematologic Malignancies
Immunotherapy

FDA Grants Accelerated Approval to Daratumumab Plus Hyaluronidase-fihj for Newly Diagnosed Light Chain Amyloidosis

On January 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to daratumumab plus hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib, cyclophosphamide, and dexamethasone for newly diagnosed light chain amyloidosis. ANDROMEDA Trial Efficacy was evaluated in ...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

FDA Approves Fam-Trastuzumab Deruxtecan-nxki for Previously Treated Patients With HER2-Positive Gastric Cancers

On January 15, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen....

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Zev A. Wainberg, MD, on Gastric/Gastroesophageal Junction Adenocarcinoma: Bemarituzumab and FOLFOX

Zev A. Wainberg, MD, of UCLA Medical Center, discusses phase II results from the FIGHT study, which combined bemarituzumab with modified FOLFOX6 in first-line treatment of advanced gastric/gastroesophageal junction adenocarcinoma. This is reportedly the first randomized trial of any FGFR inhibitor, validating this target in gastric cancer (Abstract 160).

Multiple Myeloma
Immunotherapy

Expert Point of View: Ajay K. Nooka, MD, MPH

Ajay K. Nooka, MD, MPH, Associate Professor of Hematology and Medical Oncology at Emory University and Medical Director, Winship Research Informatics Shared Resource at Winship Cancer Institute, Atlanta, considered the presentations on bispecific T-cell–engaging antibodies in myeloma to be among...

Multiple Myeloma
Immunotherapy

New Targets Explored for Bispecific T-Cell–Engaging Antibodies in Myeloma

B-cell maturation antigen (BCMA) is the most frequent target of immunotherapies in relapsed or refractory multiple myeloma, but bispecific T-cell–engaging (BiTE) antibodies with novel targets are also achieving promising results. Studies presented at the 2020 American Society of Hematology (ASH)...

Multiple Myeloma
Immunotherapy

Expert Point of View: Sagar Lonial, MD

Sagar Lonial, MD, the Anne and Bernard Gray Family Chair in Cancer, Chair and Professor of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, commented on the APOLLO trial for The ASCO Post. “APOLLO is a highly awaited study, as the use of daratumumab plus...

Multiple Myeloma
Immunotherapy

Subcutaneous Daratumumab Meets Primary Endpoint in APOLLO Trial in Myeloma

The first phase III study to evaluate the subcutaneous form of daratumumab has met its primary endpoint, investigators of the APOLLO trial reported at the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition.1 The triplet of daratumumab, pomalidomide, and low-dose dexamethasone ...

Lung Cancer
Prostate Cancer
Immunotherapy
Genomics/Genetics

FDA Pipeline: Two Reviews in NSCLC, Plus Prescribing Information Update for Darolutamide

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to lorlatinib in ALK-positive non–small cell lung cancer (NSCLC) and Breakthrough Therapy designation to the combination of tiragolumab plus atezolizumab in NSCLC with high PD-L1 expression. The FDA also updated the...

Breast Cancer
Immunotherapy

Subcutaneous Fixed-Dose vs Intravenous Pertuzumab/Trastuzumab for HER2-Positive Early Breast Cancer

As reported in The Lancet Oncology by Tan et al, the phase III FeDeriCa trial showed comparable pharmacokinetics and pathologic complete response rates with a subcutaneous (SC) fixed-dose combination of pertuzumab and trastuzumab vs the same combination administered intravenously (IV)—both given...

Leukemia
Immunotherapy

Use of a Novel CAR T-Cell Therapy in Pediatric and Adult Patients With Advanced B-Cell ALL

Pooled results of two phase I studies, reported in The Lancet by Benjamin et al, indicate that the genome-edited, donor-derived allogeneic anti-CD19 chimeric antigen receptor (CAR) T-cell product UCART19 is active and has a manageable toxicity profile in pediatric and adult patients with relapsed...

Lung Cancer
Immunotherapy

Nivolumab Indication in Small Cell Lung Cancer Withdrawn in U.S. Market

On December 29, Bristol Myers Squibb issued the following statement on nivolumab’s small cell lung cancer (SCLC) indication in the United States. In 2018, nivolumab was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of patients with SCLC whose disease...

Multiple Myeloma
Immunotherapy

Patient-Reported Outcomes With Triplet Therapy for Newly Diagnosed Multiple Myeloma

In an analysis from the phase III MAIA trial reported in the Journal of Clinical Oncology, Perrot et al found that the combination of daratumumab, lenalidomide, and dexamethasone (D-Rd) was associated with better health-related quality-of-life outcomes vs lenalidomide and dexamethasone (Rd) in...

Breast Cancer
Immunotherapy

Addition of First-Line Pembrolizumab to Chemotherapy in Metastatic Triple-Negative Breast Cancer: KEYNOTE-355

As reported in The Lancet by Javier Cortes, MD, and colleagues, the phase III KEYNOTE-355 trial has shown that the addition of pembrolizumab to chemotherapy improved progression-free survival among previously untreated patients with locally recurrent inoperable or metastatic triple-negative breast...

Gynecologic Cancers
Immunotherapy

Gemogenovatucel-T Maintenance in Stage III/IV Ovarian Cancer

In the phase IIb VITAL trial reported in The Lancet Oncology, Rocconi et al found that front-line maintenance with the autologous tumor cell vaccine gemogenovatucel-T did not improve recurrence-free survival vs placebo in patients with stage III/IV ovarian cancer in clinical complete response after ...

Solid Tumors
Immunotherapy

Naxitamab for High-Risk Neuroblastoma in Bone or Bone Marrow

On November 25, 2020, naxita­mab-gqgk (Danyelza) was granted accelerated approval for use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone...

Lymphoma
Immunotherapy

Initial Therapy for Asymptomatic Follicular Lymphoma: Start With Watch and Wait or Rituximab

For patients with indolent follicular lymphoma, generally take a conservative approach to treatment unless the patient is symptomatic, advised John P. Leonard, MD, Executive Vice-Chair of Weill Department of Medicine at Weill-Cornell Medicine/NewYork-Presbyterian, New York.1 “Prognostic scores are...

Immunotherapy
Leukemia
Lymphoma

FDA Approves Rituximab-arrx, a Biosimilar to Rituximab

On December 17, the U.S. Food and Drug Administration (FDA) approved rituximab-arrx (Riabni), a biosimilar to rituximab (Rituxan), for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener's granulomatosis), and...

breast cancer
genomics/genetics
immunotherapy

Joyce V. Lee, PhD, on Triple-Negative Breast Cancer: MYC as a Predictor of Treatment Response

Joyce V. Lee, PhD, of the University of California, San Francisco, discusses data that suggest the MYC oncogene may indicate whether a patient with triple-negative breast cancer will respond to immunotherapy. Dr. Lee’s study is the first to describe MYC downregulation of MHC-I and to demonstrate translatable approaches that may overcome immune evasion (Abstract GS1-08).

Skin Cancer
Immunotherapy

ESMO Immuno-Oncology 2020: First-Line Anti–PD-1 Therapy vs BRAF/MEK Inhibition for Advanced BRAF V600–Mutated Melanoma

Findings from a propensity-matched survival analysis presented by van Breeschoten et al at the European Society for Medical Oncology (ESMO) Immuno-Oncology Virtual Congress 2020 (Abstract 37P) suggest that patients with advanced melanoma and a BRAF V600 mutation derive an enhanced survival benefit...

Lung Cancer
Immunotherapy

ESMO Immuno-Oncology 2020: Sintilimab vs Docetaxel for Advanced Squamous NSCLC

Sintilimab provided superior clinical benefit compared to docetaxel in patients with previously treated, advanced and/or metastatic squamous non–small cell lung cancer (NSCLC), according to phase III study findings presented by Shi et al at the European Society for Medical Oncology (ESMO)...

Gynecologic Cancers
Immunotherapy

Pembrolizumab in Combination With a Therapeutic DNA Vaccine for HPV-Positive Advanced Cervical Cancer

As reported in The Lancet Oncology by Youn et al, interim results of a Korean phase II trial indicated activity with the combination of pembrolizumab plus the therapeutic DNA vaccine GX-188E in patients with human papillomavirus (HPV)-16– or HPV-18–positive advanced cervical cancer. GX-188E...

Lung Cancer
Immunotherapy

Updated Results of CASPIAN Trial: Addition of Durvalumab With or Without Tremelimumab to Chemotherapy in Extensive-Stage SCLC

As reported in The Lancet Oncology by Goldman et al, updated results from the phase III CASPIAN trial showed maintained improvement in overall survival with first-line durvalumab plus platinum/etoposide vs platinum/etoposide in patients with extensive-stage small cell lung cancer (SCLC). However,...

Breast Cancer
Immunotherapy

FDA Approves Margetuximab-cmkb Plus Chemotherapy for Previously Treated Patients With Metastatic HER2-Positive Breast Cancer

On December 16, the U.S. Food and Drug Administration (FDA) approved margetuximab-cmkb (Margenza) in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for...

leukemia
immunotherapy

Nitin Jain, MD, on B-Cell ALL: Expert Perspective on Key CAR T-Cell Treatment Advances

Nitin Jain, MD, of The University of Texas MD Anderson Cancer Center, reviews six important abstracts on CAR T-cell treatments for B-cell acute lymphoblastic leukemia (ALL): successful 24-hour manufacture of CAR T-cell therapy; ALLCAR19, a novel fast-off rate therapy; donor-derived CD19-targeted treatment; CAR 2.0 therapy to manage post-transplant relapse; UCART22, allogeneic engineered T cells expressing anti-CD22 chimeric antigen receptor; and inotuzumab ozogamicin in pediatric CD-22–positive disease (Session 614, Abstracts 159-164).

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