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lung cancer
immunotherapy

Pembrolizumab After Stereotactic Body Radiotherapy in Advanced NSCLC

In a Dutch phase II study reported in JAMA Oncology, Theelen et al found that although use of stereotactic body radiotherapy prior to pembrolizumab increased the objective response rate vs pembrolizumab alone in metastatic non–small cell lung cancer (NSCLC), the difference did not meet study...

Gastrointestinal Cancer
Immunotherapy

Brief Update on Clinical Trials of New Treatments in Gastrointestinal Cancers

The 2019 ASCO Annual Meeting provided attendees with an abundance of clinically relevant abstracts in gastrointestinal cancers. Briefly featured here are clinical trial updates on pembrolizumab in the second-line treatment of hepatocellular carcinoma (KEYNOTE-240 trial), laparoscopic vs open...

Immunotherapy
Colorectal Cancer
Lung Cancer
CNS Cancers
Kidney Cancer
Gynecologic Cancers

FDA Approves Bevacizumab Biosimilar for Five Cancer Types

ON JUNE 28, the U.S. Food and Drug Administration (FDA) approved bevacizumab-bvzr (Zirabev), a biosimilar to bevacizumab (Avastin), for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent, or metastatic nonsquamous non–small cell lung...

Immunotherapy
Lung Cancer

FDA Expands Indication for Pembrolizumab to Metastatic Small Cell Lung Cancer

ON JUNE 17, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the anti– programmed cell death protein 1 (PD-1) therapy pembrolizumab (Keytruda) as monotherapy for patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based...

Breast Cancer
Immunotherapy

Two Pivotal Studies in Breast Cancer Report Further Analyses

At the 2019 ASCO Annual Meeting, two pivotal breast cancer trials reported final or additional analyses: one confirmed the negative results seen in earlier reports,1 and the other supported a new survival benchmark.2 KRISTINE: Neoadjuvant T-DM1/Pertuzumab Sara A. Hurvitz, MD, of the David Geffen...

Immunotherapy
Skin Cancer

Expert Point of View: Vernon K. Sondak, MD

Commenting for The ASCO Post, ­melanoma expert Vernon K. Sondak, MD, Chair of the Department of Cutaneous Oncology at Moffitt Cancer Center, Tampa, maintained that the association between immuno­therapy-related toxicity and better outcomes is not yet clear. He first noted the impact of novel...

Immunotherapy
Skin Cancer

Study Finds Immune-Related Adverse Events Herald Benefit With Adjuvant Pembrolizumab in Melanoma

In the EORTC 1325/KEYNOTE-054 trial of adjuvant pembrolizumab in patients with stage III melanoma, recurrences were reduced by 44% in the immunotherapy arm, vs placebo, but this benefit increased to a 63% reduction in risk among patients developing an immune-related adverse event on treatment.1...

hepatobiliary cancer
immunotherapy

FDA Grants Breakthrough Therapy Designation to Pembrolizumab Plus Lenvatinib in Advanced HCC

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the programmed cell death protein 1 inhibitor pembrolizumab in combination with the multiple kinase inhibitor lenvatinib for the potential first-line treatment of patients with advanced unresectable...

lung cancer
immunotherapy

Immunotherapy After Locally Ablative Therapy for Oligometastatic NSCLC

In a single-center phase II trial reported in JAMA Oncology, Bauml et al found that pembrolizumab given after locally ablative therapy appeared to be associated with improved outcomes in patients with oligometastatic non­–small cell lung cancer (NSCLC). In the study, 45 evaluable...

colorectal cancer
immunotherapy

Maintenance Panitumumab vs Panitumumab/Fluorouracil/Leucovorin in RAS Wild-Type Metastatic Colorectal Cancer

In an Italian phase II trial reported in JAMA Oncology, Pietrantonio et al found that maintenance panitumumab alone was inferior in terms of progression-free survival (PFS) compared to maintenance panitumumab plus fluorouracil/leucovorin in RAS wild-type metastatic colorectal cancer. Study Details ...

lung cancer
gastroesophageal cancer
bladder cancer
gastrointestinal cancer
immunotherapy

Ramucirumab Plus Pembrolizumab in Previously Treated Advanced Gastroesophageal Cancer, NSCLC, and Urothelial Carcinoma

Results from a phase IB trial expansion stage reported in The Lancet Oncology by Herbst et al showed the combination of ramucirumab plus pembrolizumab had manageable toxicity and antitumor activity in previously treated advanced gastroesophageal cancer, non–small cell lung cancer (NSCLC), and ...

issues in oncology
immunotherapy

Incidence of Olaratumab Infusion-Related Reactions

In a study reported in the Journal of Oncology Practice, Van Tine et al found that infusion-related reactions occurred in 14.4% of patients receiving olaratumab in clinical trials, with grade ≥ 3 events occurring in 2.3%. (Olaratumab was withdrawn from the global market on April 25, 2019, based...

issues in oncology
symptom management
immunotherapy

Immune Checkpoint Inhibitor Rechallenge After Immune-Related Adverse Events

In a study reported in JAMA Oncology, Simonaggio et al found that rechallenge with an immune checkpoint inhibitor after occurrence of immune-related adverse events was associated with occurrence of an immune-related adverse event in approximately half of patients, with no increase in severity....

Immunotherapy
Lymphoma

Combination Therapy With Immunochemotherapy and an Antibody-Drug Conjugate in DLBCL

As reported in The Lancet Oncology, Hervé Tilly, MD, and colleagues found that the combination of polatuzumab vedotin, an antibody-drug conjugate targeting the CD79b component of the B-cell receptor, with immunochemotherapy showed high response rates in the phase II portion of a phase I/II study in ...

Multiple Myeloma
Immunotherapy

How Immunologic Dysregulation in the Multiple Myeloma Microenvironment May Affect Response to CAR T-Cell Therapy

Despite an avalanche of novel therapies approved by the U.S. Food and Drug Administration (FDA) over the past decade in the treatment of multiple myeloma, including proteasome inhibitors and immunomodulatory drugs, this blood cancer remains largely incurable, and nearly 13,000 people are expected...

kidney cancer
issues in oncology
immunotherapy

Benefit Seen With Targeted Therapies in Elderly and Medically Complex Patients With Metastatic RCC

Many elderly and medically complex patients with metastatic renal cell carcinoma (RCC)—who are often underrepresented in clinical trials—saw overall survival benefits from treatment with targeted therapies, according to a study that analyzed 13 years of data on Medicare patients...

gynecologic cancer
immunotherapy

GOG-0218: Final Overall Survival Results for Addition of Bevacizumab to Chemotherapy in Ovarian Cancer

The final overall survival analysis of the phase III GOG-0218 trial, reported in the Journal of Clinical Oncology by Tewari et al, showed no benefit of adding bevacizumab to chemotherapy in women with newly diagnosed, incompletely resected, advanced ovarian cancer. The trial included 1,873 women...

Immunotherapy
Lung Cancer

Combination Immunotherapy and Inhibitors of DNA Damage Repair in the Treatment of Small Cell Lung Cancer

Unlike non–small cell lung cancer (NSCLC), which has seen a paradigm shift in treatment modalities with the discovery of genetic signatures (including EGFR mutations) that are responsive to targeted drugs, systemic treatment of small cell lung cancer (SCLC) has remained largely unchanged for over...

Breast Cancer
Immunotherapy

SOPHIA Trial Tests Margetuximab in Heavily Pretreated Patients With HER2-Positive Metastatic Breast Cancer

In the phase III SOPHIA trial of 536 heavily pretreated patients with HER2-positive metastatic breast cancer, the novel anti-HER2 antibody margetuximab plus chemotherapy led to significant improvements in progression-free survival, response, and clinical benefit compared with...

Bladder Cancer
Immunotherapy

Enfortumab Vedotin After Checkpoint Inhibition in Metastatic Urothelial Cancer

A phase II study found that treatment with the antibody-drug conjugate enfortumab vedotin achieved responses in 44% of patients with locally advanced or metastatic urothelial cancer previously treated with platinum chemotherapy and a checkpoint inhibitor. This is a noteworthy study because it...

Colorectal Cancer
Immunotherapy

Targeting FOLFOXIRI Plus Bevacizumab to a Metastatic Colorectal Cancer Subset

In a population of patients with metastatic colorectal cancer deemed to be at high risk by the presence of circulating tumor cells (CTCs), first-line treatment with FOLFOXIRI plus bevacizumab improved progression-free survival by about 3 months, compared with modified FOLFOX plus bevacizumab,...

gynecologic cancer
immunotherapy

Activity of Niraparib Plus Pembrolizumab in Recurrent Ovarian Carcinoma

In a pooled analysis of the phase I/II TOPACIO/KEYNOTE-162 study reported in JAMA Oncology, Konstantinopoulos et al found evidence of activity of combined niraparib and pembrolizumab in a cohort of patients with recurrent ovarian carcinoma. Study Details The analysis included 60 evaluable women...

Lung Cancer
Immunotherapy

Neoadjuvant Immunotherapy May Benefit Patients With Early-Stage NSCLC

Neoadjuvant immunotherapy had encouraging activity and demonstrated favorable safety in patients with resectable early-stage non–small cell lung cancer (NSCLC), according to two studies presented at the 2019 ASCO Annual Meeting.1,2 This approach has the potential to boost the survival rate in...

symptom management
immunotherapy

Treatment of Immune Checkpoint Inhibitor Immune-Related Cutaneous Adverse Events

In a study reported in the Journal of Clinical Oncology, Phillips et al found that immune-related cutaneous adverse events in patients receiving immune checkpoint inhibitors generally responded to symptom- and phenotype-directed dermatologic therapies, and that biologic therapies were effective in...

skin cancer
immunotherapy

ECHO-301/KEYNOTE-252: Addition of Epacadostat to Pembrolizumab in Unresectable or Metastatic Melanoma

As reported in The Lancet Oncology by Long et al, the phase III ECHO-301/KEYNOTE-252 trial showed no improvement in progression-free or overall survival with the addition of the IDO1 inhibitor epacadostat to pembrolizumab in unresectable stage III or stage IV melanoma. Study Details In the...

symptom management
immunotherapy

Multidisciplinary Approach for Addressing Immunotherapy-Related Toxicities

New research published in JNCCN—Journal of the National Comprehensive Cancer Network and presented by Jarushka Naidoo, MBBCh, at the NCCN 2019 Annual Conference suggests that institutions and networks that utilize immunotherapy should consider establishing multidisciplinary teams for...

multiple myeloma
immunotherapy

FDA Approves Daratumumab in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed, Transplant-Ineligible Patients With Multiple Myeloma

Today, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The application received approval ...

lymphoma
skin cancer
immunotherapy

15-ICML: Final Data From ALCANZA: Brentuximab Vedotin for CD30-Positive CTCL

Final analyses from the ALCANZA study, a phase III trial investigating brentuximab vedotin vs physician’s choice for the treatment of CD30-positive cutaneous T-cell lymphoma (CTCL), were presented by Horwitz et al at the 15th International Conference on Malignant Lymphoma (ICML; Abstract...

lung cancer
immunotherapy

Outcomes of Immune Checkpoint Inhibitor Treatment in Patients With Advanced NSCLC Receiving Baseline Corticosteroids

In a single-center study reported in the Journal of Clinical Oncology, Ricciuti et al found better outcomes with immune checkpoint inhibitor treatment among patients with advanced non–small cell lung cancer (NSCLC) receiving baseline prednisone equivalent of ≥ 10 mg daily for...

breast cancer
immunotherapy

Niraparib Plus Pembrolizumab in Advanced Triple-Negative Breast Cancer

In the phase II TOPACIO/KEYNOTE-162 trial reported in JAMA Oncology, Vinayak et al found evidence of activity of combined niraparib and pembrolizumab in a cohort of patients with advanced or metastatic triple-negative breast cancer, with higher response rates seen in patients with BRCA mutations or ...

lymphoma
immunotherapy

15-ICML: Post Hoc Analysis of MAVORIC Study: Mogamulizumab in Patients With Previously Treated Cutaneous T-Cell Lymphoma

The MAVORIC study—presented by Scarisbrick et al at the 15th International Conference on Malignant Lymphoma (ICML; Abstract 034)—examined the efficacy of mogamulizumab, a monoclonal antibody that targets the CC chemokine receptor 4 (CCR4), in patients with previously treated mycosis...

kidney cancer
immunotherapy

Activity of Nivolumab for Renal Cell Carcinoma Brain Metastases

In an analysis of the phase II GETUG-AFU 26 NIVOREN study reported in the Journal of Clinical Oncology, Flippot et al found that nivolumab had limited activity in patients with previously untreated brain metastases from clear cell renal cell carcinoma. The study assessed nivolumab in patients with ...

Head and Neck Cancer
Immunotherapy

Synergistic Relationship Between Radiotherapy and Immunotherapy for Squamous Cell Carcinoma of the Head and Neck

Recent technologic improvements in radiotherapy now offer an unprecedented opportunity to enhance immune response, and going forward, may play a role in the definitive treatment of head and neck cancer, according to William Stokes, MD, Assistant Professor in the Department of Radiation Oncology at...

Immunotherapy
Head and Neck Cancer

Immune Therapies Emerging in Disease-Specific Treatment of HPV-Positive Head and Neck Cancer

Patients with human papillomavirus (HPV)-related head and neck cancer stand to benefit greatly from immunotherapy, according to Nabil F. Saba, MD, FACP, Director, Head and Neck Medical Oncology Program, Winship Cancer Institute of Emory University, Atlanta. He added, immunotherapy will likely play...

CNS Cancers
Immunotherapy

Update on Early-Stage Studies of Novel Treatments in Glioblastoma

Outcomes are typically grim for patients with recurrent glioblastoma multiforme. At the 2019 Annual Scientific Meeting of the American Association of Neurological Surgeons (AANS), three early-stage studies hinted at ways that standard treatments might be made more effective. Metronomic Dosing of...

Head and Neck Cancer
Immunotherapy

Expert Point of View: Vanita Noronha, MD

The KEYNOTE-048 trial is practice-changing, according to its invited discussant, Vanita Noronha, MD, Professor of Oncology at Tata Memorial Centre in Mumbai, India. Although a number of questions remain to be answered, she said the take-home message is that the study “met most of its primary...

Leukemia
Immunotherapy

Fixed-Duration Venetoclax Plus Obinutuzumab as First-Line Treatment in Older Patients With CLL Who Have Comorbidities

A fixed-duration regimen of venetoclax plus obinutuzumab demonstrated superior progression-free survival, complete response rates, and minimal residual disease (MRD) negativity compared with chlorambucil plus obinutuzumab as first-line therapy for older patients with chronic lymphocytic leukemia...

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...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

Expert Point of View: Ian Chau, MD

IAN CHAU, MD, a consultant medical oncologist at the Gastrointestinal and Lymphoma Units of The Royal Marsden NHS Foundation Trust in London and Surrey, United Kingdom, was the invited discussant of KEYNOTE-062. In an interview with The ASCO Post, he first commented that although single-agent...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

KEYNOTE-062: Pembrolizumab Is a New First-Line Option in Gastric/Gastroesophageal Junction Cancer

KEYNOTE-062, a study of first-line treatment in patients with advanced gastric or gastroesophageal junction adenocarcinoma, found pembrolizumab to be noninferior to chemotherapy and perhaps better than chemotherapy in a subgroup of patients. The results were reported at the 2019 ASCO Annual Meeting ...

skin cancer
immunotherapy

Comparison of Combination Dosing Schedules of Neoadjuvant Ipilimumab/Nivolumab in Macroscopic Stage III Melanoma

In the phase II OpACIN-neo study reported in The Lancet Oncology, Rozeman et al identified a promising dosing schedule for neoadjuvant ipilimumab/nivolumab in macroscopic stage III melanoma. Study Design The trial included 86 evaluable patients with resectable stage III melanoma involving the...

lymphoma
immunotherapy

Rate and Outcome of Late Relapses in Patients With DLBCL Treated With Immunochemotherapy

In a study reported in the Journal of Clinical Oncology, Wang et al identified the rates and outcomes of relapses of diffuse large B-cell lymphoma (DLBCL) in patients who had achieved 24-month event-free survival (EFS) after immunochemotherapy.   Study Details The study involved 1,324...

leukemia
immunotherapy

EHA 2019: ASCEND Trial Compares Acalabrutinib vs Investigator’s Choice in Relapsed or Refractory CLL

The randomized, global, multicenter, open-label phase III ASCEND trial evaluated the efficacy and safety of acalabrutinib vs investigator’s choice of rituximab/idelalisib or rituximab/bendamustine in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Ghia et al presented ...

multiple myeloma
immunotherapy

EHA 2019: CASSIOPEIA Trial Examines Addition of Daratumumab to Standard Treatment Before and After ASCT in Multiple Myeloma

In the phase III CASSIOPEIA trial, reported in The Lancet and presented at the 24th Annual Congress of the European Hematology Association (EHA; Abstract S145) by Moreau et al, daratumumab plus bortezomib/thalidomide/dexamethasone (D-VTd) given before and after autologous stem cell transplantation...

breast cancer
immunotherapy

2019 ASCO: 3-Year Outcomes in the KRISTINE Trial on Neoadjuvant Trastuzumab Emtansine Plus Pertuzumab in HER2-Positive Breast Cancer

As reported at the 2019 ASCO Annual Meeting (Abstract 500) and in the Journal of Clinical Oncology by Hurvitz et al, 3-year outcomes in the phase III KRISTINE trial showed that neoadjuvant trastuzumab emtansine (T-DM1) plus pertuzumab was associated with increased risk of event-free survival events ...

breast cancer
immunotherapy

TONIC: PD-1 Blockade in Metastatic Triple-Negative Breast Cancer

Clinical and translational data from the TONIC trial, published in a research letter by Voorwerk et al in Nature Medicine, indicated that short-term doxorubicin and cisplatin may induce a more favorable tumor microenvironment and increase the likelihood of response to programmed cell death protein...

lung cancer
immunotherapy

KEYNOTE-001: 5-Year Overall Survival With Pembrolizumab in Advanced NSCLC

Long-term follow-up of the phase I KEYNOTE-001 study reported in the Journal of Clinical Oncology by Garon et al showed that pembrolizumab monotherapy was associated with an estimated 5-year overall survival of 23.2% for treatment-naive patients and 15.5% for previously treated patients with...

multiple myeloma
immunotherapy

MAIA Trial: Addition of Daratumumab to Lenalidomide/Dexamethasone in Untreated Myeloma Ineligible for ASCT

In the phase III MAIA trial reported in The New England Journal of Medicine, Facon et al found that the addition of daratumumab to lenalidomide/dexamethasone significantly improved progression-free survival in previously untreated multiple myeloma ineligible for autologous stem cell transplantation ...

breast cancer
immunotherapy

Peter Schmid, MD, PhD, and Hope S. Rugo, MD, on Breast Cancer: Next Steps in Immunotherapy

Hope S. Rugo, MD, of the University of California, San Francisco, and Peter Schmid, MD, PhD, of Barts Cancer Institute, Queen Mary University of London, discuss ongoing trials of immunotherapy for early triple-negative breast cancer; immunotherapy in other disease subtypes such as estrogen receptor–positive and HER2-positive; and checkpoint inhibition in PD-L1–negative disease.  

colorectal cancer
hepatobiliary cancer
myelodysplastic syndromes
immunotherapy

FDA Pipeline: Designations and Reviews in Myelofibrosis, Myelodysplastic Syndromes, Biliary Tract Cancer, and T-Cell Receptor Therapy

Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for momelotinib in myelofibrosis, granted Priority Review to a biologics license application for luspatercept in myelodyslastic syndromes and beta-thalassemia, granted Orphan Drug designation for a new chemical...

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