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Hepatobiliary Cancer
Immunotherapy

Nivolumab for Advanced Refractory Biliary Tract Cancer

In a phase II trial reported in JAMA Oncology, Kim et al found that nivolumab showed antitumor activity in patients with advanced refractory biliary tract cancer. As noted by the investigators, there currently is no established second-line systemic treatment for biliary tract cancer. Study Details...

Skin Cancer
Immunotherapy

Expert Point of View: Charles Sawyers, MD

“The hypothesis of combining kinase inhibitors with checkpoint inhibitors could be a fantastic idea,” said formal study discussant Charles Sawyers, MD, of Memorial Sloan Kettering Cancer Center, New York. “This trial [IMspire150] is positive, and that is great news. Triple therapy is superior to...

Skin Cancer
Immunotherapy

AACR 2020: Triplet Regimen Improves Progression-Free Survival in Advanced Melanoma in IMspire150 Trial

The addition of the checkpoint inhibitor atezolizumab to two targeted therapies (the BRAF inhibitor vemurafenib and the MEK inhibitor cobimetinib) as initial therapy improved outcomes compared with the two targeted therapies plus placebo in patients with newly diagnosed BRAF V600E/K–mutant advanced ...

Hepatobiliary Cancer
Immunotherapy

AACR 2020: Atezolizumab Alone or in Combination With Cobimetinib for Biliary Tract Cancer

A randomized multicenter study of a combination of immunotherapy with a targeted therapy improved cancer control for some patients with biliary tract cancer, according to research presented by Yarchoan et al at the American Association for Cancer Research (AACR) Virtual Annual Meeting (Abstract...

Breast Cancer
Immunotherapy

Abemaciclib/Fulvestrant/Trastuzumab for Patients With Previously Treated HR-Positive, HER2-Positive Advanced Breast Cancer

In the phase II monarcHER trial reported in The Lancet Oncology, Sara M. Tolaney, MD, and colleagues found that the combination of abemaciclib, fulvestrant, and trastuzumab prolonged progression-free survival vs trastuzumab plus standard-of-care chemotherapy in patients with previously treated...

Colorectal Cancer
Gastrointestinal Cancer
Immunotherapy

Regorafenib Plus Nivolumab in Advanced Gastric and Colorectal Cancers

In a Japanese phase Ib/dose-expansion trial reported in the Journal of Clinical Oncology, Fukuoka et al found that the combination of regorafenib and nivolumab showed activity in patients with previously treated gastric cancer and colorectal cancer with microsatellite stable/mismatch...

breast cancer
immunotherapy

Lajos Pusztai, MD, PhD, on Breast Cancer: I-SPY2 Trial on Durvalumab, Olaparib, and Paclitaxel

Lajos Pusztai, MD, PhD, of Yale Cancer Center, discusses study results on durvalumab in combination with olaparib and paclitaxel as neoadjuvant treatment in patients with high-risk HER2-negative stage II/III breast cancer. Compared with patients who received chemotherapy alone, the combination improved pathologic complete response, even in women with triple-negative breast cancer (Abstract CT011).

Immunotherapy
Skin Cancer

Neoadjuvant Nivolumab for Resectable Merkel Cell Carcinoma

As reported in the Journal of Clinical Oncology by Suzanne L. Topalian, MD, and colleagues, neoadjuvant treatment with nivolumab was found to produce pathologic complete response in approximately half of patients with resectable Merkel cell carcinoma enrolled in the phase I/II CheckMate 358 trial....

Immunotherapy
COVID-19

Negotiating the Obstacles to Conducting Clinical Trials of Immunotherapy During the Coronavirus Pandemic

Coronavirus disease 2019 (COVID-19) is perhaps the biggest challenge health-care systems have ever had to face. As part of a series of interviews The ASCO Post is conducting with oncologists, we talked with Charles G. Drake, MD, PhD, about the impact of COVID-19 on his practice and on the conduct...

Multiple Myeloma
Immunotherapy

FDA Approves Daratumumab and Hyaluronidase-fihj in Multiple Myeloma

On May 1, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for adult patients with newly diagnosed, relapsed, or refractory multiple myeloma. This new product allows for subcutaneous dosing of daratumumab. Daratumumab and hyaluronidase-fihj...

Breast Cancer
Immunotherapy

AACR 2020: I-SPY2 Trial: Durvalumab/Olaparib/Paclitaxel ‘Graduates’ in HER2-Negative Breast Cancer

The I-SPY2 trial found that the combination of the checkpoint inhibitor durvalumab, the PARP inhibitor olaparib, and the taxane paclitaxel followed by doxorubicin/cyclophosphamide as neoadjuvant therapy improved pathologic complete responses vs paclitaxel followed by doxorubicin/cyclophosphamide...

Leukemia
Immunotherapy

High- vs Low-Dose Anti-CD19 CAR T-Cell Therapy in Patients With Relapsed or Refractory CLL

In a study reported in the Journal of Clinical Oncology by Noelle V. Frey, MD, and colleagues, a higher dose of anti-CD19 chimeric antigen receptor (CAR) T cells was associated with a higher rate of complete response in patients with relapsed or refractory chronic lymphocytic leukemia, with...

Gynecologic Cancers
Immunotherapy

Nivolumab/Ipilimumab vs Nivolumab Alone in Recurrent or Persistent Ovarian Cancer

In a phase II NRG Oncology trial (NRG GY003) reported in the Journal of Clinical Oncology, Dmitriy Zamarin, MD, PhD, and colleagues found that the addition of ipilimumab to nivolumab improved objective response rate and progression-free survival in women with persistent or recurrent epithelial...

Immunotherapy

FDA Approves New Pembrolizumab Dosing Regimen

On April 28, the U.S. Food and Drug Administration (FDA) granted accelerated approval to a new dosing regimen for pembrolizumab (Keytruda)—400 mg every 6 weeks—across all currently approved adult indications, in addition to the current 200 mg every 3 weeks dosing regimen. The approval was based on...

Multiple Myeloma
Immunotherapy

Isatuximab-irfc for Previously Treated Multiple Myeloma

On March 2, 2020, the CD-38-directed cytolytic antibody isatuximab-irfc (Sarclisa) was approved for use in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.1,2...

Immunotherapy
Solid Tumors

PD-1 Inhibition in Mismatch Repair–Deficient/Microsatellite Instability–High Cancers Other Than Colorectal Cancer

Mismatch repair (MMR)-deficiency and consequently high DNA microsatellite instability (MSI-H) are associated with high tumor mutational burden. A high mutational load increases the potential number of neoantigens that can be presented by the tumor cell and recognized by host lymphocytes. Detection...

Immunotherapy
Solid Tumors

NCI-MATCH Subprotocol Finds Nivolumab Active in Mismatch Repair–Deficient Cancers Other Than Colorectal Cancer

In a study (NCI-MATCH trial subprotocol, arm Z1D) reported in the Journal of Clinical Oncology, Nilofer S. Azad, MD, of Johns Hopkins Medicine Sidney Kimmel Comprehensive Cancer, and colleagues found that nivolumab was active in mismatch repair (MMR)-deficient noncolorectal cancers.1 As stated by...

Multiple Myeloma
Immunotherapy

Addition of Isatuximab to Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma

As reported in The Lancet by Michel Attal, MD, of the Institut Universitaire du Cancer Toulouse Oncopole, France, and colleagues, the phase III ICARIA-MM trial has shown that the addition of the CD38-targeted antibody isatuximab to pomalidomide and low-dose dexamethasone significantly improved...

Colorectal Cancer
Immunotherapy

Expert Point of View: John M. Carethers, MD, and Joseph J. Y. Sung, MD, PhD

Session moderators for the CheckMate 142 presentation at the Gastrointestinal Cancers Symposium were John M. Carethers, MD, the John G Searle Professor (and Chair) of Internal Medicine at the University of Michigan, Ann Arbor, and Joseph J. Y. Sung, MD, PhD, the Mok Hing You Professor of Medicine...

Colorectal Cancer
Immunotherapy

CheckMate 142 Updated Analysis: First-Line Nivolumab Plus Low-Dose Ipilimumab in MSI-H/dMMR Metastatic Colorectal Cancer

As a first-line regimen for patients with metastatic colorectal tumors that are microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR), the combination of nivolumab and low-dose ipilimumab yielded an objective response rate of 64%, a complete response rate of 9%, and a disease...

Issues in Oncology
Immunotherapy

Do HIV Positivity and Autoimmune Disease Preclude Treatment With Checkpoint Inhibitors?

Can patients with cancer and preexisting autoimmune disorders safely benefit from immunotherapy? The answer has been unclear, with only retrospective studies and anecdotal reports guiding oncologists. This subpopulation of patients has largely been excluded from clinical trials out of concerns over ...

Immunotherapy
Breast Cancer
Skin Cancer
Lung Cancer

What’s the Current Status of Neoadjuvant Immunotherapy?

For several tumor types, can the successes achieved with immunotherapy in the metastatic and adjuvant settings be replicated in the neoadjuvant setting? An explosion in clinical trials—with more than 300 listed on ClinicalTrials.gov—point to “yes.” “The neoadjuvant use of immunotherapy is of great ...

Head and Neck Cancer
Immunotherapy

Study Finds Chemoradiation Plus Bevacizumab Safe and Feasible in Locally or Regionally Advanced Nasopharyngeal Cancer

The addition of bevacizumab to the current standard of care of chemoradiation therapy is safe and feasible for the treatment of locally or regionally advanced nasopharyngeal cancer, according to data presented at the 2020 Multidisciplinary Head and Neck Cancers Symposium.1 “I’m pleased to report...

Head and Neck Cancer
Immunotherapy

Expert Point of View: Charu Aggarwal, MD, MPH

Charu Aggarwal, MD, MPH, Leslye M. Heisler Assistant Professor for Lung Cancer Excellence at the Perelman Center for Advanced Medicine, University of Pennsylvania, underscored the paucity of treatment options for metastatic head and neck squamous cell carcinoma. “Even though pembrolizumab is...

Head and Neck Cancer
Immunotherapy

Pembrolizumab Plus Cetuximab Shows Antitumor Activity in Squamous Cell Head and Neck Cancer

The first trial to evaluate anti–­programmed cell death protein 1 (PD-1) blockade combined with epidermal growth factor receptor (EGFR) inhibition in head and neck squamous cell carcinoma demonstrates promising activity of the drug combination in patients with platinum-refractory or -ineligible...

Immunotherapy
Hepatobiliary Cancer

Nivolumab/Ipilimumab in Patients With Sorafenib-Pretreated Hepatocellular Carcinoma

On March 10, 2020, the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) was granted accelerated approval for treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib.1-3 Supporting Efficacy Data The approval was based on findings in a cohort...

covid-19
immunotherapy

Joseph C. Alvarnas, MD, on the Increased Risk of Side Effects for Patients With Cancer and COVID-19

Joseph C. Alvarnas, MD, of the City of Hope National Medical Center, discusses the patients with cancer who are at an increased risk for developing serious complications from COVID-19, including those receiving bone marrow or stem cell transplants and CAR-T cell therapy, and what they can do to protect themselves. Filmed April 17, 2020.

Immunotherapy

Gut Microbiota Emerging as Key Player in Response to Immunotherapy

The microbiome—and the foods that feed it—is emerging as an important determinant of a patient’s response to immunotherapy. Much of the research in this area comes from The University of Texas MD Anderson Cancer Center, as described at the 2020 ASCO-SITC Clinical Immuno-Oncology Symposium by...

Leukemia
Immunotherapy

ELEVATE-TN: Acalabrutinib With or Without Obinutuzumab vs Chlorambucil/Obinutuzumab in Patients With Previously Untreated CLL

As reported in The Lancet by Jeff P. Sharman, MD, and colleagues, the phase III ELEVATE-TN trial showed significantly improved progression-free survival with both acalabrutinib/obinutuzumab and acalabrutinib monotherapy vs chlorambucil/obinutuzumab in patients with treatment-naive chronic...

Hematologic Malignancies
Immunotherapy

Anti-CD22 CAR T-Cell Therapy for CD22-Positive B-Cell Malignancies

In an update of a phase I trial of anti-CD22 chimeric antigen receptor (CAR) T-cell therapy in children and young adults with relapsed or refractory CD22-positive B-cell malignancies reported in the Journal of Clinical Oncology, Shah et al described findings in cohorts receiving treatment at doses...

Bladder Cancer
Immunotherapy

'Switch Maintenance' Pembrolizumab for Metastatic Urothelial Cancer

In a phase II study reported in the Journal of Clinical Oncology, Matthew D. Galsky, MD, and colleagues found that maintenance pembrolizumab produced additional responses and improved progression-free survival vs placebo in patients with metastatic urothelial cancer who had at least stable disease...

Immunotherapy
Symptom Management

Recurrence of Immune-Related Adverse Events After Checkpoint Inhibitor Rechallenge in Patients With Cancer

A study reported in JAMA Oncology by Dolladille et al using pharmacovigilance data from the World Health Organization database VigiBase found that the same immune-related adverse events (irAEs) associated with discontinuation of immune checkpoint inhibitor therapy recurred in 28.8% of patients...

Lung Cancer
Immunotherapy

Addition of Pembrolizumab to Docetaxel for Previously Treated Immunotherapy-Naive Patients With Advanced NSCLC

In the single-institution phase II PROLUNG trial reported in JAMA Oncology, Arrieta et al found that the addition of pembrolizumab to docetaxel improved objective response rate and progression-free survival in immunotherapy-naive patients with advanced non–small cell lung cancer (NSCLC) who...

Solid Tumors
Immunotherapy

Durvalumab for Solid Tumors in Patients With Virologically Controlled HIV-1 Infection

In the Spanish phase II DURVAST trial reported in JAMA Oncology, Gonzalez-Cao et al found that treatment with durvalumab was feasible, safe, and active in patients with solid tumors and virologically controlled HIV-1 infection. As stated by the investigators, “Concerns about the safety and...

Lung Cancer
Immunotherapy

First-Line Durvalumab With or Without Tremelimumab vs Chemotherapy for Metastatic NSCLC: MYSTIC Study

As reported in JAMA Oncology by Naiyer A. Rizvi, MD, and colleagues, the phase III MYSTIC trial showed no overall survival benefit with durvalumab vs chemotherapy, or overall or progression-free survival benefit with durvalumab/tremelimumab vs chemotherapy, as first-line treatment in patients with...

Immunotherapy
COVID-19

Immune Checkpoint Inhibitor Treatment for Patients With Cancer During the COVID-19 Pandemic

In an article published in the journal Immunotherapy, Melissa Bersanelli, MD, of the Medical Oncology Unit, University Hospital of Parma, Italy, discusses controversies regarding the use of immune checkpoint inhibitor therapy in patients with cancer during the COVID-19 pandemic, suggesting that...

Colorectal Cancer
Immunotherapy

Neoadjuvant Immunotherapy in Early-Stage Colon Cancer

Patients with localized colon cancer may benefit from a short course of neoadjuvant immunotherapy, according to findings from the exploratory phase II NICHE study published by Myriam Chalabi, MD, and colleagues in Nature Medicine.  Study Results Forty patients with two colon cancer subtypes—either ...

Lung Cancer
Immunotherapy

Activity of Pembrolizumab in Patients With NSCLC Brain Metastases

As reported in The Lancet Oncology by Sarah B. Goldberg, MD, MPH, and colleagues, continued follow-up of the non–small cell lung cancer (NSCLC) cohort of a single-institution phase II trial showed that pembrolizumab produced responses in patients with brain metastases and programmed cell death...

Immunotherapy
Solid Tumors
Lung Cancer
Bladder Cancer
Gynecologic Cancers
CNS Cancers

FDA Pipeline: Priority Reviews for Immunotherapy Based on Biomarker Status, Combination First-Line Therapy in Lung Cancer

Over the past week, the U.S. Food and Drug Administration (FDA) granted Priority Review to an immunotherapeutic agent for solid tumors with a high tumor mutational burden and to a combination treatment for the first-line treatment of metastatic or recurrent non–small cell lung cancer. The agency...

Hematologic Malignancies
Immunotherapy

Highlights From Transplantation and Cellular Therapy Meetings of ASTCT and CIBMTR

The Combined Annual Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) were held in Orlando, Florida, from February 19–23, 2020. The scientific program addressed the most timely issues in ...

Breast Cancer
Immunotherapy

Updates From Selected Clinical Trials in Breast Cancer

Each year, The ASCO Post asks Jame Abraham, MD, FACP, Chairman of the Department of Hematology and Medical Oncology at Taussig Cancer Institute and Professor of Medicine at the Cleveland Clinic Lerner College of Medicine, to offer his picks for the most important research presented at 2019 San...

Lung Cancer
Pancreatic Cancer
Immunotherapy

Expert Point of View: Timothy A. Yap, MBBS, PhD, FRCP

Semaphorin 4D (SEMA4D, and its receptor, plexin B1) is broadly expressed in malignant tumors. Aside from other “normal functions” in tumors, SEMA4D influences the infiltration and distribution of leukocytes into the microenvironment, and its inhibition promotes functional immune infiltration....

Lung Cancer
Pancreatic Cancer
Immunotherapy

SEMA4D Inhibition: A Novel Means of Improving Immune Response

A novel class of inhibitors may hold some promise for boosting responses to checkpoint inhibitors and for sensitizing poorly immunogenic tumors, such as pancreatic cancer, to immunotherapy. The drug targets semaphorin 4D (SEMA4D), a glycoprotein expressed on the cell membranes of many tumor types....

Skin Cancer
Immunotherapy

Expert Point of View: Jarushka Naidoo, MBBCh

Discussant of the abstract on antibiotic exposure, Jarushka Naidoo, MBBCh, Assistant Professor of Oncology and Attending Physician at the Sidney Kimmel Cancer Center at Johns Hopkins University, said that Mr. Chu and colleagues have added to the recent literature examining concurrent use of...

Skin Cancer
Immunotherapy

Prior Antibiotic Use Linked to Poorer Survival in Patients With Advanced Melanoma Receiving Immune Checkpoint Inhibitors

Treatment with antibiotics prior to immune checkpoint inhibitor therapy may confer poorer overall survival and an increased risk of colitis in patients with advanced melanoma, according to data presented at the 2020 ASCO-SITC Clinical Immuno-Oncology Symposium.1 The largest institutional...

Head and Neck Cancer
Immunotherapy

Expert Point of View: Sue Sun Yom, MD, PhD

Sue Sun Yom, MD, PhD, Professor of Radiation Oncology & Otolaryngology–Head and Neck Surgery at the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, said there is “reasonableness to further investigation” of the combination of programmed cell death...

Head and Neck Cancer
Immunotherapy

Pembrolizumab Plus Radiotherapy Worthy of Further Study in Locally Advanced Squamous Cell Head and Neck Cancer

The combination of the checkpoint inhibitor pembrolizumab and definitive radiation therapy appears to be a safe and feasible option for patients with locally advanced head and neck cancer who are not eligible for cisplatin, according to data presented at the 2020 Multidisciplinary Head and Neck...

Breast Cancer
Immunotherapy

Immunotherapy ‘Comes of Age’ in Breast Cancer

Immunotherapeutics in breast cancer will likely not be limited to late-stage triple-negative breast cancer. Earlier lines, combination regimens, and expansion into different disease subtypes should become part of this emerging landscape, according to Hope S. Rugo, MD, FASCO, Professor of Medicine...

Prostate Cancer
Immunotherapy

T-Cell Responses and Benefit From Treatment With Ipilimumab in Patients With Metastatic Castration-Resistant Prostate Cancer

Although patients with metastatic castration-resistant prostate cancer typically have limited responses to immunotherapy, a subset of patients with pretreatment evidence of active T-cell responses in their tumors experienced prolonged survival following treatment with ipilimumab in a phase II...

Colorectal Cancer
Immunotherapy

FDA Approves Encorafenib/Cetuximab for BRAF V600E–Mutated Metastatic Colorectal Cancer

On April 8, the U.S. Food and Drug Administration (FDA) approved encorafenib (Braftovi) in combination with cetuximab (Erbitux) for the treatment of pretreated adult patients with metastatic colorectal cancer with a BRAF V600E mutation detected by an FDA-approved test. BEACON CRC Efficacy was...

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