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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 ...

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...

symptom management
immunotherapy

Resuming Immune Checkpoint Inhibitor Therapy After Immune-Mediated Diarrhea and Colitis

In a retrospective multicenter study reported in the Journal of Clinical Oncology, Abu-Sbeih et al found that approximately one-third of patients resuming immune checkpoint inhibitor therapy after improvement in immune-mediated diarrhea and colitis experienced a recurrence of the adverse effect....

skin cancer
immunotherapy

2019 ASCO: OPTiM Study on T-VEC for Unresectable Melanoma

New research on the immunotherapy talimogene laherparepvec (T-VEC)—an injectable oncolytic virus—for patients with unresectable melanoma was presented by Milhem et al at the 2019 ASCO Annual Meeting (Abstract 9524). Researchers reported the ad hoc analysis of progression-free survival...

cns cancers
immunotherapy

2019 ASCO: Combination Therapy With SurVaxM in Newly Diagnosed Glioblastoma

Ahluwalia et al shared research results on SurVaxM at the 2019 ASCO Annual Meeting, reporting that combination therapy with the immunotherapy vaccine was more effective than standard therapy for nearly all patients with newly diagnosed glioblastoma in a phase II trial (Abstract 2016). SurVaxM...

leukemia
immunotherapy

2019 ASCO: CLL14 Trial Evaluates First-Line Venetoclax/Obinutuzumab in Previously Untreated CLL

The phase III CLL14 trial—reported by Fischer et al at the 2019 ASCO Annual Meeting (Abstract 7502) and in The New England Journal of Medicine—found that the BCL2 inhibitor venetoclax plus the monoclonal antibody obinutuzumab prolonged progression-free survival vs obinutuzumab and...

lymphoma
immunotherapy

CheckMate 205: Nivolumab in Newly Diagnosed, Advanced Classical Hodgkin Lymphoma

Findings in a cohort of the phase II CheckMate 205 study, reported in the Journal of Clinical Oncology by Ramchandren et al, indicate that nivolumab monotherapy followed by nivolumab plus doxorubicin, vinblastine, and dacarbazine (N-AVD) is highly active in newly diagnosed, advanced-stage classical ...

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...

lymphoma
immunotherapy

FDA Approves Polatuzumab Vedotin-piiq in Combination With Bendamustine and a Rituximab Product for DLBCL

On June 10, the U.S. Food and Drug Administration (FDA) granted accelerated approval to polatuzumab vedotin-piiq (Polivy), a CD79b-directed antibody-drug conjugate, in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma...

bladder cancer
immunotherapy

Adverse Events and Outcomes in Patients Receiving Anti–PD-1/PD-L1 Antibody Treatment for Advanced Urothelial Cancer

In an analysis reported in the Journal of Clinical Oncology, Maher et al found that treatment-related adverse events of special interest and immune-mediated adverse events were more common among patients with advanced urothelial cancer with vs without response to anti–programmed cell death...

lymphoma
multiple myeloma
prostate cancer
immunotherapy

FDA Pipeline: Reviews and Designations in Multiple Myeloma, Lymphoma, Prostate Cancer

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review for daratumumab in combination with a triplet therapy in multiple myeloma, Breakthrough Therapy designation to copanlisib for marginal zone lymphoma, and Fast Track designation for ARV-110 in metastatic...

lung cancer
immunotherapy

2019 ASCO: NEOSTAR: Neoadjuvant Nivolumab Plus Ipilimumab in Early-Stage, Resectable NSCLC

Neoadjuvant treatment with nivolumab plus ipilimumab resulted in an overall major pathologic response rate of 33% of treated patients with early-stage, resectable non–small cell lung cancer (NSCLC). With these results, the combination immunotherapy met the prespecified trial...

lymphoma
immunotherapy

2019 ASCO: Rituximab, Lenalidomide, and Ibrutinib Prior to Chemotherapy in DLBCL

Results of the phase II Smart Start trial revealed that combination targeted therapy consisting of rituximab, lenalidomide, and ibrutinib had an 84.6% overall response rate (ORR) and 38.5% complete response rate (CRR) when given prior to any chemotherapy for newly diagnosed patients with a...

lung cancer
immunotherapy

IMpower130: Addition of First-Line Atezolizumab to Chemotherapy in Metastatic Nonsquamous NSCLC

As reported in The Lancet Oncology by West et al, the phase III IMpower130 trial found that the addition of atezolizumab to carboplatin plus nab-paclitaxel significantly improved overall and progression-free survival in first-line treatment of stage IV nonsquamous non–small cell lung cancer...

bladder cancer
immunotherapy

2019 ASCO: Enfortumab Vedotin Shows Activity in Previously Treated, Locally Advanced or Metastatic Urothelial Cancer

The single-arm, phase II EV-201 trial showed treatment with enfortumab vedotin—an agent targeting Nectin-4, a protein found in 97% of urothelial cancers—produced responses in 44% of patients with locally advanced or metastatic forms of urothelial cancer. Patients had previously been...

gynecologic cancers
immunotherapy

2019 ASCO: Novel Immunotherapy for Recurrent, Metastatic, or Persistent Cervical Cancer

There is a high, unmet need for effective treatments for patients with recurrent, metastatic, or persistent cervical cancer—most patients are young, and survival rates are poor. Adoptive cell transfer using tumor-infiltrating lymphocytes (TILs) has demonstrated durable responses in some...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

2019 ASCO: KEYNOTE-062: Pembrolizumab With or Without Chemotherapy vs Chemotherapy in Advanced Gastric or GEJ Adenocarcinoma

The randomized, phase III KEYNOTE-062 trial achieved its primary endpoint, showing that for patients with programmed cell death ligand 1 (PD-L1)-positive, HER2-negative, advanced gastric or gastroesophageal junction (GEJ) cancer, initial therapy with pembrolizumab resulted in noninferior overall...

lung cancer
immunotherapy

2019 ASCO: KEYNOTE-001: 5-Year Survival Data for Patients With Advanced NSCLC Treated With Pembrolizumab

Five-year data from the phase Ib KEYNOTE-001 trial showed that treatment with pembrolizumab was safe and effective and substantially increased overall survival in patients with advanced non–small cell lung cancer (NSCLC). Specifically, 23.2% of people who had not previously been treated with...

head and neck cancer
immunotherapy

2019 ASCO: Final Analysis of KEYNOTE-048: First-Line Pembrolizumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

The phase III KEYNOTE-048 trial is examining the efficacy of pembrolizumab alone, pembrolizumab/cisplatin or carboplatin/fluorouracil (5-FU), or cetuximab/cisplatin or carboplatin/5-FU as first-line therapy for recurrent or metastatic head and neck squamous cell carcinoma. At the second interim...

lung cancer
immunotherapy

Addition of Bevacizumab to Carboplatin/Pemetrexed in Nonsquamous NSCLC

New research published by Bagley et al in JNCCN—Journal of the National Comprehensive Cancer Network used a large real-world data set to demonstrate a modest but consistent survival benefit associated with adding bevacizumab to carboplatin/pemetrexed in advanced nonsquamous non–small...

lymphoma
immunotherapy

Polatuzumab Vedotin and Immunochemotherapy in Previously Untreated Diffuse Large B-Cell Lymphoma

As reported in The Lancet Oncology, Tilly et al 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 previously...

bladder cancer
immunotherapy

CheckMate 032: Extended Follow-up of Nivolumab and Nivolumab/Ipilimumab Cohorts in Previously Treated Metastatic Urothelial Carcinoma

As reported in the Journal of Clinical Oncology by Sharma et al, follow-up of the cohort receiving nivolumab at 1 mg/kg plus ipilimumab at 3 mg/kg the phase I/II CheckMate 032 trial showed the regimen produced high levels of activity in platinum-treated, unresectable, locally advanced or metastatic ...

kidney cancer
immunotherapy

IMmotion151: First-Line Atezolizumab/Bevacizumab vs Sunitinib in Metastatic Renal Cell Carcinoma

In the phase III IMmotion151 trial reported in The Lancet, Rini et al found that atezolizumab plus bevacizumab prolonged progression-free survival vs sunitinib in patients with previously untreated, programmed cell death ligand 1 (PD-L1)-positive, metastatic renal cell carcinoma. Study Details...

hepatobiliary cancer
immunotherapy

Early-Stage Study of Nivolumab Alone or in Combination With Cisplatin/Gemcitabine in Biliary Tract Cancer

In a Japanese phase I trial reported by Ueno et al in The Lancet Gastroenterology & Hepatology, researchers found nivolumab showed activity and had a manageable safety profile in patients with unresectable or recurrent biliary tract cancer. Methods The open-label phase I trial was conducted...

skin cancer
immunotherapy

Predicting Response to Immunotherapy in Squamous Cell Carcinoma

According to a study published by Kacew et al in the European Journal of Cancer, copy number alterations in the chromosome 3q arm may be linked to immunotherapy response in patients with cutaneous squamous cell carcinoma. In fact, this and other genetic markers may prove to be useful...

colorectal cancer
immunotherapy

Tumor Mutational Burden as a Marker of Response to Immunotherapy in MSI-High Metastatic Colorectal Cancer

Foundational research recently published by Schrock et al in Annals of Oncology may help patients with microsatellite instability (MSI)-high metastatic colorectal cancer decide whether to choose immunotherapy or chemotherapy as their first treatment option. “Immunotherapy is the new,...

sarcoma
immunotherapy

Axitinib Plus Pembrolizumab in Advanced Sarcomas

In a phase II trial reported in The Lancet Oncology, Wilky et al found evidence of activity of axitinib plus pembrolizumab in advanced sarcomas, including alveolar soft-part sarcoma. Study Details The study involved 33 patients with advanced or metastatic sarcomas, including alveolar soft-part...

lymphoma
immunotherapy

Addition of Decitabine to Camrelizumab in Relapsed or Refractory Classical Hodgkin Lymphoma

In a single-center phase II trial reported in the Journal of Clinical Oncology, Nie et al found a higher complete response rate with the addition of low-dose decitabine to the programmed cell death protein 1 (PD-1) inhibitor camrelizumab in anti–PD-1 treatment–naive patients with...

multiple myeloma
immunotherapy

Anti-BCMA CAR T-Cell Therapy in Relapsed or Refractory Multiple Myeloma

In a phase I trial reported in The New England Journal of Medicine, Raje et al found that bb2121, a chimeric antigen receptor (CAR) T-cell therapy targeting B-cell maturation antigen (BCMA), was safe in heavily pretreated patients with relapsed or refractory multiple myeloma. Investigators reported ...

skin cancer
immunotherapy

PD-1 Inhibitor–Associated Cutaneous Toxicity and Clinical Outcomes in Advanced Melanoma

In a research letter published in JAMA Oncology, Quach et al found that cutaneous toxicities related to anti–programmed cell death protein 1 (PD-1) treatment—specifically, vitiligo and rash—were associated with improved clinical outcomes in advanced melanoma. Study Details The...

symptom management
immunotherapy

Treatment-Related Adverse Events With PD-1/PD-L1 Inhibitors in Clinical Trials

In a systematic review and meta-analysis reported in JAMA Oncology, Wang et al characterized treatment-related adverse event profiles associated with monotherapy use of programmed cell death protein 1 (PD-1) and programmed cell death ligand 1 (PD-L1) inhibitors in clinical trials. Study Details...

gynecologic cancers
immunotherapy

GOG-252: Intravenous vs Intraperitoneal Chemotherapy in Advanced Ovarian Carcinoma

In the phase III NRG Oncology/Gynecologic Oncology Group (GOG)-252 study reported in the Journal of Clinical Oncology, Walker et al found no progression-free survival benefit of postsurgical intraperitoneal (IP) chemotherapy vs intravenous (IV) chemotherapy, each combined with bevacizumab, in...

lung cancer
immunotherapy

Association Between Clinical Outcomes and Patient Characteristics/Genomic Profiles in Lung Cancer

As reported in JAMA, Singal et al used a clinicogenomic database in routine clinical practice to identify associations between treatment outcomes and patient characteristics or tumor genomic profiles in the setting of non–small cell lung cancer (NSCLC). The study cohort of 4,064 patients...

colorectal cancer
immunotherapy

IMblaze370: Atezolizumab With or Without Cobimetinib vs Regorafenib in Previously Treated Advanced Colorectal Cancer

In the phase III IMblaze370 trial reported in The Lancet Oncology, Eng et al found no survival benefit with third-line atezolizumab with or without cobimetinib vs regorafenib in patients with locally advanced or metastatic colorectal cancer. Study Details The open-label trial included 363...

health-care policy
hematologic malignancies
immunotherapy

ASH President Comments on Medicare Proposal for CAR T-Cell Therapy

Earlier this week, the Centers for Medicare & Medicaid Services (CMS) proposed to improve the reimbursement currently given to hospitals that provide chimeric antigen receptor T-cell (CAR-T) therapy to patients with blood cancer as part of the Fiscal Year 2020 Inpatient Prospective Payment...

kidney cancer
immunotherapy

FDA Approves Pembrolizumab Plus Axitinib for First-Line Treatment of Advanced Renal Cell Carcinoma

On April 19, 2019, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). KEYNOTE-426 Approval was based on KEYNOTE-426, a randomized, multicenter, open-label trial conducted in ...

lung cancer
immunotherapy

KEYNOTE-042: Pembrolizumab vs Chemotherapy in Previously Untreated Locally Advanced or Metastatic NSCLC With PD-L1 Expression ≥ 1%

As reported in The Lancet by Mok et al, the KEYNOTE-042 trial has shown an improvement in overall survival with pembrolizumab vs standard chemotherapy in previously untreated patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) without a sensitizing EGFR mutation or ...

gynecologic cancers
immunotherapy

KEYNOTE-158: Pembrolizumab in Previously Treated Advanced Cervical Cancer

As reported in the Journal of Clinical Oncology by Chung et al, the phase II KEYNOTE-158 trial showed activity of pembrolizumab in previously treated programmed cell death ligand 1 (PD-L1)-positive advanced cervical cancer. The study supported the 2018 accelerated approval of pembrolizumab in this...

lung cancer
immunotherapy

FDA Expands Pembrolizumab Indication for NSCLC in First-Line Setting

Today, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the first-line treatment of patients with stage III non–small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or those with metastatic NSCLC....

lung cancer
immunotherapy

ELCC 2019: Does Maintenance Immunotherapy Improve Survival in Patients With Advanced SCLC?

Maintenance immunotherapy did not improve survival in patients with extensive-stage small cell lung cancer (SCLC), according to late-breaking results from the CheckMate 451 study presented today by Owonikoko et al at the European Lung Cancer Congress 2019 (Abstract LBA1_PR). Around 60% to 70% of...

lung cancer
issues in oncology
immunotherapy

ELCC 2019: Immunotherapy in Elderly Patients With Advanced NSCLC

Two studies reported at the European Lung Cancer Congress (ELCC) 2019 provided new insights on the efficacy and safety of immunotherapy in elderly patients with advanced non–­small cell lung cancer (NSCLC). Although around half of all people newly diagnosed with NSCLC are elderly (Pallis ...

gynecologic cancers
immunotherapy

Lenvatinib Plus Pembrolizumab in Advanced Endometrial Cancer

In an interim analysis of a phase II study reported in The Lancet Oncology, Makker et al found that lenvatinib plus pembrolizumab was active in advanced endometrial cancer. Study Details In the study, 54 patients from 11 sites with metastatic endometrial cancer unselected for microsatellite...

lymphoma
immunotherapy

AUGMENT: Addition of Lenalidomide to Rituximab in Relapsed or Refractory Indolent Lymphoma

In the phase III AUGMENT trial reported in the Journal of Clinical Oncology, Leonard et al found that the addition of lenalidomide to rituximab significantly prolonged progression-free survival in patients with relapsed or refractory indolent lymphoma. Study Details The double-blind trial...

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