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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 ...

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...

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...

breast cancer
immunotherapy

Peter Schmid, MD, PhD, and Hope S. Rugo, MD, on Metastatic Triple-Negative Breast Cancer: Atezolizumab Plus Nab-paclitaxel

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 an update of the IMpassion130 interim overall survival analysis of atezolizumab plus nab-paclitaxel in previously untreated locally...

breast cancer
immunotherapy

Hope S. Rugo, MD, and Matteo Lambertini, MD, PhD, on the SOPHIA Trial in HER2-Positive Metastatic Breast Cancer: Chemotherapy Plus Margetuximab vs Trastuzumab

Matteo Lambertini, MD, PhD, of the University of Genova and Policlinico San Martino Hospital, and Hope S. Rugo, MD, of the University of California, San Francisco, discuss findings from the SOPHIA trial on margetuximab plus chemotherapy vs trastuzumab plus chemotherapy in patients with...

gynecologic cancers
immunotherapy

Mansoor Raza Mirza, MD, and Don S. Dizon, MD, on Recurrent Platinum-Sensitive Ovarian Cancer: Niraparib Plus Bevacizumab

Don S. Dizon, MD, of the Lifespan Cancer Institute, and Mansoor Raza Mirza, MD, of Copenhagen University Hospital, discuss study findings that showed, compared with niraparib alone, niraparib plus bevacizumab improved progression-free survival in women with recurrent platinum-sensitive ovarian...

breast cancer
immunotherapy

Sara A. Hurvitz, MD, on HER2-Positive Breast Cancer: KRISTINE Trial on Neoadjuvant Trastuzumab, Pertuzumab, and Chemotherapy

Sara A. Hurvitz, MD, of the David Geffen School of Medicine, University of California Los Angeles, discusses 3-year outcomes from the first phase III study to test a non-conventional regimen for the neoadjuvant and adjuvant treatment of HER2-positive breast cancer (Abstract 500).  

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...

lymphoma
immunotherapy

Jason Westin, MD, on Diffuse Large B-Cell Lymphoma: Rituximab, Lenalidomide, and Ibrutinib Prior to Chemotherapy

Jason Westin, MD, of The University of Texas MD Anderson Cancer Center, discusses findings of the Smart Start study on the chemotherapy-free combination of rituximab, lenalidomide, and ibrutinib in newly diagnosed diffuse large B-cell lymphoma (Abstract 7508).

leukemia
lymphoma
immunotherapy

William G. Wierda, MD, PhD, on Immunotherapy for Relapsed/Refractory CLL/SLL: Results From TRANSCEND CLL 004

William G. Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, discusses the TRANSCEND CLL 004 trial, which studied the use of an experimental CD19-directed CAR T-cell product in heavily pretreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (Abstract ...

skin cancer
immunotherapy

Ahmad A. Tarhini, MD, PhD, on High-Risk Melanoma: Adjuvant Ipilimumab vs High-Dose Interferon-α2b

Ahmad A. Tarhini, MD, PhD, of Emory University and Winship Cancer Institute, discusses phase III findings from the U.S. Intergroup E1609 trial, which showed survival benefits for patients with resected high-risk melanoma—for the first time in the history of melanoma adjuvant therapy (Abstract...

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...

colorectal cancer
immunotherapy

Javier Sastre, MD, PhD, on Colorectal Cancer: Bevacizumab and FOLFOXIRI in Metastatic Disease

Javier Sastre, MD, PhD, of Hospital Clinico San Carlos, discusses phase III findings on the assessment of circulating tumor cells as a prognostic factor and FOLFOXIRI plus bevacizumab combination outcomes for patients with poor-prognosis colorectal cancer (Abstract 3507).  

sarcoma
immunotherapy

William D. Tap, MD, on Soft-Tissue Sarcomas: ANNOUNCE Trial on Doxorubicin and Olaratumab

William D. Tap, MD, of Memorial Sloan Kettering Cancer Center, discusses negative study findings on doxorubicin plus olaratumab vs doxorubicin plus placebo, which showed no difference in overall survival between the two treatments in patients with advanced soft-tissue sarcomas. The manufacturer is...

lung cancer
immunotherapy

Gilberto Lopes, MD, MBA, on the RELAY Trial in Metastatic NSCLC: Erlotinib and Ramucirumab in EGFR Mutant–Positive Disease

Gilberto Lopes, MD, MBA, of the Sylvester Comprehensive Cancer Center at the University of Miami, offers commentary on phase III findings from the RELAY study, which showed that erlotinib plus ramucirumab led to superior progression-free survival in previously untreated patients with EGFR...

kidney cancer
immunotherapy

Ziad Bakouny, MD, and Toni K. Choueiri, MD, on Renal Cell Carcinoma: Checkpoint Inhibitors and Genomic Characterization of Sarcomatoid/Rhabdoid Disease

Toni K. Choueiri, MD, and Ziad Bakouny, MD, both of Dana-Farber Cancer Institute, discuss a retrospective review of genomically profiled patients with sarcomatoid/rhabdoid renal cell cancer who were found to have better outcomes with immune checkpoint inhibitors and to harbor mutations associated...

solid tumors
immunotherapy

Sarah Abou Alaiwi, MD, and Toni K. Choueiri, MD, on Checkpoint Inhibitors: Overall Survival and Polybromo-Associated Mutations

Toni K. Choueiri, MD, and Sarah Abou Alaiwi, MD, both of Dana-Farber Cancer Institute, discuss the association of polybromo-associated BAF-type mutations with overall survival in patients with different solid tumors treated with checkpoint inhibitors (Abstract 103).

multiple myeloma
immunotherapy

Paul G. Richardson, MD, on Relapsed or Refractory Multiple Myeloma: Adding Isatuximab to Pomalidomide and Low-Dose Dexamethasone

Paul G. Richardson, MD, of Dana-Farber Cancer Institute, discusses findings from the phase III ICARIA-MM trial showing that isatuximab, pomalidomide, and low-dose dexamethasone significantly improved progression-free survival and overall response vs pomalidomide and dexamethasone (Abstract 8004).  

lung cancer
immunotherapy

Miriam Knoll, MD, and Richard J. White, DO, on Non–Small Cell Lung Cancer: Predicting Radiotherapy/Immunotherapy Treatment Outcomes

Miriam Knoll, MD, of Hackensack University Medical Center, and Richard J. White, DO, of Allegheny Health Network, discuss improved overall survival among younger female patients with non–small cell lung cancer who have a lower comorbidity score, lower grade, private insurance, and treatment with...

gynecologic cancers
immunotherapy

Yoland C. Antill, MD, on Endometrial Cancer: PHAEDRA Trial on Durvalumab and Mismatch Repair Status

Yoland C. Antill, MD, of Cabrini Health, discusses phase II data on the effect of durvalumab, a PD-L1 inhibitor, as a single agent in the setting of recurrent or advanced endometrial cancer. Her research compares the response in mismatch repair–deficient and –proficient tumors (Abstract 5501).

lung cancer
immunotherapy

Suresh S. Ramalingam, MD, on Non–Small Cell Lung Cancer: Pemetrexed, Bevacizumab, or Both as Maintenance Therapy

Suresh S. Ramalingam, MD, of Winship Cancer Institute, Emory University, discusses findings from the ECOG-ACRIN 5508 study, which showed that single-agent bevacizumab or pemetrexed is the optimal maintenance therapy for advanced nonsquamous NSCLC (Abstract 9002).

bladder cancer
immunotherapy

Matt D. Galsky, MD, on Urothelial Cancer: Pembrolizumab vs Placebo After First-Line Chemotherapy

Matt D. Galsky, MD, of The Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai, discusses phase II study findings that show switch maintenance with pembrolizumab significantly improves progression-free survival in the metastatic setting (Abstract 4504).

bladder cancer
immunotherapy

Jonathan E. Rosenberg, MD, on Urothelial Carcinoma: Adding Bevacizumab to Gemcitabine and Cisplatin

Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, discusses results from the phase III Alliance trial, which showed that adding bevacizumab to gemcitabine and cisplatin did not improve overall survival in patients with metastatic urothelial carcinoma, but did improve...

kidney cancer
immunotherapy

Neeraj Agarwal, MD, and Thomas Powles, MD, PhD, on Renal Cell Carcinoma: KEYNOTE-426 on First-Line Pembrolizumab Plus Axitinib vs Sunitinib

Neeraj Agarwal, MD, of Huntsman Cancer Institute, University of Utah Health Care, and Thomas Powles, MD, PhD, of Queen Mary University of London, discuss phase III study findings on outcomes with combination therapy for intermediate/poor-risk and sarcomatoid subgroups of renal cell carcinoma...

bladder cancer
immunotherapy

Daniel P. Petrylak, MD, on Urothelial Cancer: Enfortumab Vedotin Monotherapy for Locally Advanced or Metastatic Disease

Daniel P. Petrylak, MD, of Yale School of Medicine, discusses study results on enfortumab vedotin monotherapy for locally advanced or metastatic urothelial cancer previously treated with platinum and immune checkpoint inhibitors (Abstract LBA4505).

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...

lung cancer
immunotherapy

David J. Kwiatkowski, MD, PhD, on Non–Small Cell Lung Cancer: Neoadjuvant Immunotherapy for Resectable Disease

David J. Kwiatkowski, MD, PhD, of Brigham and Women’s Hospital and Dana-Farber Cancer Institute, discusses an interim analysis and biomarker data from a multicenter study showing that 19% of patients with NSCLC had a major pathologic response to preoperative treatment with atezolizumab (Abstract...

head and neck cancer
immunotherapy

Danny Rischin, MD, on Head and Neck Squamous Cell Carcinoma: KEYNOTE-048 Trial on Pembrolizumab

Danny Rischin, MD, of Peter MacCallum Cancer Centre, discusses phase III results that support pembrolizumab with and without platinum-based chemotherapy plus fluorouracil as new first-line standards of care for recurrent or metastatic head and neck squamous cell carcinoma (Abstract 6000).

gynecologic cancers
immunotherapy

Kamran A. Ahmed, MD, on Cervical Cancer: Stereotactic Body Radiation Therapy Plus Atezolizumab

Kamran A. Ahmed, MD, of the H. Lee Moffitt Cancer Center and Research Institute, reports on a trial in progress that is investigating whether treatment with atezolizumab plus hypofractionated radiation therapy will improve the objective response rate compared with atezolizumab alone in patients...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Josep Tabernero, MD, PhD, on Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: Pembrolizumab With or Without Chemotherapy vs Chemotherapy

Josep Tabernero, MD, PhD, of the Vall d’Hebron Institute of Oncology, discusses phase III findings of the KEYNOTE-062 study showing that, for some patients with advanced gastric or gastroesophageal junction cancer, pembrolizumab may improve survival and may be an effective alternative to...

lung cancer
immunotherapy

Edward B. Garon, MD, on Advanced Non–Small Cell Lung Cancer: KEYNOTE-001 Trial on Pembrolizumab

Edward B. Garon, MD, of the David Geffen School of Medicine at the University of California, Los Angeles, discusses long-term survival data on patients with advanced non–small cell lung cancer treated with pembrolizumab and those with PD-L1 expressed in at least half of their tumor cells (Abstract...

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...

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