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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).

breast cancer
immunotherapy

Sara A. Hurvitz, MD, on Triple-Negative Breast Cancer: Sacituzumab Govitecan and Chemotherapy

Sara A. Hurvitz, MD, of the David Geffen School of Medicine at UCLA, discusses phase III data from the ASCENT study of the antibody-drug conjugate sacituzumab govitecan vs chemotherapy in patients with previously treated metastatic triple-negative breast cancer (Abstract GS3-06).

Skin Cancer
Immunotherapy

ESMO Immuno-Oncology 2020: Tebentafusp Shows Activity in Metastatic Uveal Melanoma

Tebentafusp is a novel bispecific molecule consisting of an affinity-enhanced T-cell receptor fused to an anti-CD3 effector that can redirect T cells to target gp100-positive cells. The agent showed clinical benefit, including target lesion reduction, in patients with metastatic uveal melanoma,...

Bladder Cancer
Immunotherapy

ESMO Immuno-Oncology 2020: Adjuvant Atezoliumab for Patients With Muscle-Invasive Urothelial Cancer and Presence of Postsurgical ctDNA

Patients with muscle-invasive urothelial cancer and postsurgical circulating tumor DNA (ctDNA) positivity have high risk of disease recurrence following cystectomy and experienced improved clinical outcomes with adjuvant atezolizumab as compared to patients undergoing observation. These...

Lung Cancer
Immunotherapy

ESMO Immuno-Oncology 2020: Does Pleural Effusion Affect Survival in Patients Treated With Immunotherapy for NSCLC?

Patients with non–small cell lung cancer (NSCLC) who have pleural effusion, especially those requiring pleural evacuation, experienced poorer survival when treated with immune checkpoint inhibitors, according to findings presented by Epaillard et al at the European Society for Medical Oncology...

Colorectal Cancer
Immunotherapy

Pembrolizumab vs Chemotherapy in First-Line Treatment of Microsatellite Instability–High Advanced Colorectal Cancer: KEYNOTE-177 Trial

As reported in The New England Journal of Medicine, the second interim analysis of the phase III KEYNOTE-177 trial has shown significantly prolonged progression-free survival with pembrolizumab vs fluorouracil (5-FU)-based chemotherapy as first-line treatment of patients with advanced...

Breast Cancer
Immunotherapy

SABCS 2020: Patient-Reported Outcomes From the Phase III IMpassion031 Trial

Adding an immune checkpoint inhibitor to a standard chemotherapy regimen for patients with early-stage triple-negative breast cancer did not affect patients’ ability to perform day-to-day activities more than treatment with chemotherapy alone, according to research presented by Elizabeth...

Lymphoma
Immunotherapy

ASH 2020: Phase II ZUMA-12 Study Investigates First-Line Axicabtagene Ciloleucel for High-Risk Large B-Cell Lymphoma

The phase II ZUMA-12 trial found that axicabtagene ciloleucel, an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, is a safe and effective first-line therapy for patients with high-risk large B-cell lymphoma. These results were presented by Sattva S. Neelapu, MD, and colleagues...

lymphoma
immunotherapy

Andrew D. Zelenetz, MD, PhD, on Mantle Cell Lymphoma: Expert Perspective on Key Clinical Trials

Andrew D. Zelenetz, MD, PhD, of Memorial Sloan Kettering Cancer Center, offers his expert views on five treatment studies in mantle cell lymphoma focusing on the next-generation BTK inhibitor LOXO-305; lisocabtagene maraleucel; minimal residual disease monitoring following autologous stem cell transplantation with or without rituximab maintenance; the antibody-drug conjugate VLS-101; and venetoclax, lenalidomide, and rituximab (Abstracts 117, 118, 120, 121, 122).

lymphoma
immunotherapy

Andrew D. Zelenetz, MD, PhD, on Mantle Cell Lymphoma: Immunochemotherapy Plus Lenalidomide

Andrew D. Zelenetz, MD, PhD, of Memorial Sloan Kettering Cancer Center, discusses phase II results from a single-center study that explored a novel approach for high-risk patients with mantle cell lymphoma. Among patients with TP53 wild-type disease, the data suggested this treatment was effective (Abstract 119).

multiple myeloma
immunotherapy

Meletios A. Dimopoulos, MD, on Multiple Myeloma: Daratumumab, Pomalidomide, and Dexamethasone

Meletios A. Dimopoulos, MD, of the University of Athens, discusses data from the phase III APOLLO study, which evaluated the use of subcutaneous daratumumab plus pomalidomide and dexamethasone, vs pomalidomide and dexamethasone alone, in patients with relapsed or refractory multiple myeloma (Abstract 412).

Hepatobiliary Cancer
Immunotherapy

Meta-analysis of Outcomes With Systemic Therapy in First- and Second-Line Treatments of Advanced HCC

In a systematic review and network meta-analysis reported in JAMA Oncology, Mohamad Bassam Sonbol, MD, of Mayo Clinic Cancer Center, Phoenix, and colleagues, found that atezolizumab plus bevacizumab outperformed other regimens in the first-line treatment of advanced hepatocellular carcinoma (HCC)...

Breast Cancer
Immunotherapy

Improved Outcomes With Neoadjuvant Paclitaxel Plus Trastuzumab/Lapatinib vs Paclitaxel/Trastuzumab in HER2-Positive Breast Cancer

In a 7-year follow-up of the phase III CALGB 40601/Alliance trial reported in the Journal of Clinical Oncology, ­Aranzazu Fernandez-Martinez, MD, of Lineberger Comprehensive Center, University of North Carolina, Chapel Hill, and colleagues found that neoadjuvant paclitaxel combined with a dual...

Hepatobiliary Cancer
Immunotherapy

ASCO Releases Guideline on Systemic Therapy for Advanced Hepatocellular Carcinoma

ASCO has released a new evidence-based clinical practice guideline to assist in clinical decision-making for patients with advanced hepatocellular carcinoma.1 “Advanced hepatocellular carcinoma has transitioned from a disease where we had a single approved therapy for patients to one where we now...

Immunotherapy
Solid Tumors
Sarcoma

Progress Report on Checkpoint Inhibitors in Rare Tumors

Immune checkpoint inhibitors may prove to be effective in treating patients with two rare cancer types—leptomeningeal metastases and angiosarcoma, according to early-phase clinical trials reported at the 2020 Annual Meeting of the Society for Immunotherapy of Cancer (SITC), which was held virtually ...

Breast Cancer
Immunotherapy

Immunotherapy for Triple-Negative Breast Cancer: An Evolving Story

Immunotherapy with checkpoint inhibitors, established as a treatment of many solid tumors, may be finding a role in the treatment of breast cancer. The current state of the art regarding immunotherapy for triple-negative breast cancer was the focus of a talk by Heather L. McArthur, MD, MPH, Medical ...

Lung Cancer
Immunotherapy

Expert Point of View: Joel W. Neal, MD, PhD

Invited discussant of the abstract, Joel W. Neal, MD, PhD, Associate Professor of Medicine at Stanford University, called this real-world analysis novel,1 given the decreasing number of patients treated with single-agent immunotherapy. “I think we’re unlikely to have a larger prospective study [in...

Lung Cancer
Immunotherapy

Lung Cancer Progression-Free Survival With Immunotherapy Varies Significantly by Tumor-Mutation Subtype, Real-World Data Show

A real-world study of single-agent immune checkpoint inhibitors in driver-mutated non–small cell lung cancer (NSCLC) has demonstrated significant variation in progression-free survival between mutation subtypes, according to data presented during the International Association for the Study of Lung...

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