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Immunotherapy
Skin Cancer

Continued Benefit of First-Line Nivolumab vs Dacarbazine in Advanced BRAF Wild-Type Melanoma

The 5-year outcomes of the ­CheckMate 066 trial, reported in the Journal of Clinical Oncology by Caroline Robert, MD, PhD, of Gustave Roussy, Villejuif, France,and colleagues, show continued benefit of first-line nivolumab vs dacarbazine in advanced BRAF wild-type melanoma and support evidence that ...

Immunotherapy
Skin Cancer

Advanced Melanoma: Lenvatinib Plus Pembrolizumab After Disease Progression on Anti-PD-1 Based Therapy

Checkpoint inhibitors can be lifesaving for many patients with advanced melanoma, but those who experience disease progression currently have few treatment options. The combination of a tyrosine kinase inhibitor and an anti–PD-1 agent may offer some hope in this setting, according to a study of...

Bladder Cancer
Immunotherapy

Co-Leader of Immunotherapy Trial Reflects on ‘Practice-Changing’ Results in Advanced Bladder and Other Urinary Tract Cancers

In a large, randomized clinical trial, researchers evaluated the immunotherapy drug avelumab for patients with advanced urothelial cancer. The findings of the trial, called the JAVELIN Bladder 100 study, are “very exciting,” even “practice-changing,” said the trial’s co-leader, Petros Grivas, MD,...

Breast Cancer
Immunotherapy

Sacituzumab Govitecan Yields Survival Benefit as Third-Line Treatment in Triple-Negative Breast Cancer: ASCENT Trial

Based on results from a phase I/II clinical trial, the antibody drug conjugate sacituzumab govitecan was recently granted accelerated approval in the treatment of patients with advanced triple-negative breast cancer, contingent on a larger study confirming its benefit. The confirmatory phase III...

Lung Cancer
Kidney Cancer
Leukemia
Solid Tumors
Gastroesophageal Cancer
Gastrointestinal Cancer
Pancreatic Cancer
Prostate Cancer
Genomics/Genetics
Immunotherapy

FDA Pipeline: Priority Reviews in EGFR-Mutant Lung Cancer, Advanced Renal Cell Carcinoma; Fast Track Designations in CLL and Solid Tumors

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for EGFR-mutant lung cancer and advanced renal cell carcinoma; granted Fast Track designation to agents in chronic lymphocytic leukemia (CLL) and locally advanced or metastatic solid tumors; and more....

Gynecologic Cancers
Immunotherapy

Addition of Bevacizumab to Paclitaxel in Relapsed Ovarian Sex Cord–Stromal Tumors

In the phase II ALIENOR trial reported in JAMA Oncology, Isabelle Ray-Coquard, MD, and colleagues found that the addition of bevacizumab to paclitaxel did not improve the 6-month progression-free rate among women with relapsed ovarian sex cord–stromal tumors. Study Details The study, performed in...

Gynecologic Cancers
Immunotherapy

Camrelizumab Plus Apatinib in Previously Treated Patients With Advanced Cervical Cancer

In the Chinese phase II CLAP study reported in the Journal of Clinical Oncology, Lan et al found that the combination of the anti–PD-1 antibody camrelizumab and the VEGFR inhibitor apatinib produced high response rates in previously treated women with advanced cervical cancer. Study Details The...

Bladder Cancer
Immunotherapy

Neoadjuvant Dual Checkpoint Blockade in Certain Patients With Localized Bladder Cancer

Neoadjuvant combination therapy with the anti–CTLA-4 therapy tremelimumab and the anti–PD-1 therapy durvalumab was well tolerated and showed early signs of activity in patients ineligible to receive cisplatin-based chemotherapy, all of whom had tumors with high-risk features that are associated...

Hematologic Malignancies
Immunotherapy

Long-Term Follow-up of Anti-CD19 CAR T-Cell Therapy in Relapsed B-Cell Malignancies

As reported in the Journal of Clinical Oncology by Cappell et al, long-term follow-up of a National Cancer Institute phase I trial has shown that anti-CD19 chimeric antigen receptor (CAR) T-cell therapy for various relapsed B-cell malignancies produced responses lasting 3 years or longer in half of ...

Lymphoma
Immunotherapy

FDA Extends the Approval of Pembrolizumab for Patients With Classical Hodgkin Lymphoma

On October 14, the U.S. Food and Drug Administration (FDA) extended the approval of pembrolizumab (Keytruda) for the following indications:   Adult patients with relapsed or refractory classical Hodgkin lymphoma Pediatric patients with refractory classical Hodgkin lymphoma or classical Hodgkin...

Lung Cancer
Immunotherapy

Addition of Cetuximab to Afatinib in First-Line Treatment of EGFR-Mutant NSCLC

As reported in the Journal of Clinical Oncology by Sarah B. Goldberg, MD, MPH, and colleagues, final results of the phase II SWOG S1403 trial show no progression-free survival benefit with afatinib plus cetuximab vs afatinib alone in the first-line treatment of EGFR-mutant advanced non–small cell...

Breast Cancer
Immunotherapy

Addition of Atezolizumab to T-DM1 in Previously Treated Patients With HER2-Positive Advanced Breast Cancer

In the phase II KATE2 trial reported in The Lancet Oncology, Leisha A. Emens, MD, and colleagues found that the addition of atezolizumab to ado-trastuzumab emtansine (T-DM1) did not improve progression-free survival in patients with advanced HER2-positive breast cancer progressing after previous...

Gastroesophageal Cancer
Immunotherapy

KEYNOTE-181 Trial: Second-Line Pembrolizumab vs Chemotherapy in Advanced Esophageal Cancer

As reported in the Journal of Clinical Oncology by Takashi Kojima, MD, and colleagues, the phase III KEYNOTE-181 trial has shown that second-line pembrolizumab improved overall survival vs investigator’s choice of chemotherapy in patients with advanced or metastatic esophageal cancer with a PD-L1...

Lymphoma
Immunotherapy

Identifying Characteristics of Infused CAR T Cells Associated With Efficacy and Toxicity in Patients With Large B-Cell Lymphoma

Researchers have identified molecular and cellular characteristics of anti-CD19 chimeric antigen receptor (CAR) T-cell infusion products associated with how patients with large B-cell lymphoma respond to treatment and develop side effects. The research team also found that early changes in...

Hematologic Malignancies
Immunotherapy
Gastroesophageal Cancer
Gastrointestinal Cancer

FDA Pipeline: Designations for Treatments of Rare Blood Cancer, B-Cell Malignancies, and Gastric Cancers

Recently, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to an antibody-drug conjugate for the treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN); gave Fast Track designation to a novel chimeric antigen...

Breast Cancer
Immunotherapy

NeoALTTO Trial: Final Analysis Examines Neoadjuvant Lapatinib/Trastuzumab in HER2-Positive Breast Cancer

Final analysis of results from a randomized clinical trial of lapatinib and trastuzumab given before surgery in patients with early HER2-positive breast cancer has found that women who had a pathologic complete response survived longer without cancer recurrence than patients who did not. This was...

Lung Cancer
Immunotherapy

Addition of Nivolumab to Neoadjuvant Chemotherapy in Resectable Stage IIIA NSCLC

In the Spanish phase II NADIM trial reported in The Lancet Oncology, Provencio et al found that the addition of nivolumab to neoadjuvant chemotherapy and the use of adjuvant nivolumab were associated with high 24-month rates of progression-free survival in patients with resectable stage IIIA...

Gastrointestinal Cancer
Immunotherapy

Expert Point of View: Elizabeth Smyth, MD

The overall survival benefit for PD-L1 CPS ≥ 5 tumors in CheckMate 649 is a game-changer. An oxaliplatin doublet plus chemotherapy should become a standard of care for these patients,” according to Elizabeth Smyth, MD, an oncology consultant at Cambridge University Hospital NHS Foundation Trust in...

Gastrointestinal Cancer
Immunotherapy

Nivolumab Plus Chemotherapy: New Standard of Care in Advanced Gastric Cancer?

As first-line treatment for advanced gastric cancer, nivolumab plus chemotherapy leads to significantly improved progression-free and overall survival over chemotherapy alone, investigators reported during a Presidential Symposium of the European Society for Medical Oncology (ESMO) Virtual Congress ...

Multiple Myeloma
Immunotherapy

Carfilzomib and Daratumumab With Dexamethasone for Relapsed or Refractory Multiple Myeloma

On August 20, 2020, carfilzomib and daratumumab were approved for use in combination with dexamethasone for treatment of adults with relapsed or refractory multiple myeloma who have received one to three lines of therapy.1-3 Supporting Efficacy Data Approval was based on findings in two clinical...

Kidney Cancer
Immunotherapy

Expert Point of View: Camillo Porta, MD

Acknowledging there are now expanded therapeutic choices in the first-line setting for advanced renal cell carcinoma, formal study discussant Camillo Porta, MD, of the University of Bari Aldo Moro, Italy, said that studies of the immunotherapy combinations could not be compared directly. “We should ...

Kidney Cancer
Immunotherapy

First-Line Nivolumab Plus Cabozantinib Improves Outcomes vs Sunitinib in Advanced Renal Cell Carcinoma

The combination of nivolumab plus cabozantinib was found to be superior to the former standard, sunitinib, in the first-line treatment of advanced or metastatic renal cell carcinoma, according to the results of the phase III CheckMate 9ER trial reported at the European Society for Medical Oncology...

Immunotherapy

City of Hope Scientists Explore Combination Immunotherapy for Solid Tumors

City of Hope scientists have combined two immunotherapies—an oncolytic virus and chimeric antigen receptor (CAR) T-cell therapy—to target solid tumors that are otherwise difficult to treat with CAR T-cell therapy alone, according to a recent study in Science Translational Medicine.1 In preclinical...

Skin Cancer
Immunotherapy

Five-Year Outcomes: First-Line Nivolumab vs Dacarbazine in Advanced BRAF Wild-Type Melanoma

The 5-year outcomes of the CheckMate 066 trial, reported in the Journal of Clinical Oncology by Caroline Robert, MD, PhD, and colleagues, showed continued benefit of first-line nivolumab vs dacarbazine in advanced BRAF wild-type melanoma. The results add to data indicating that nivolumab can be...

Bladder Cancer
Immunotherapy

Avelumab Maintenance Therapy in Advanced or Metastatic Urothelial Carcinoma

In the phase III JAVELIN Bladder 100 trial reported in The New England Journal of Medicine, Thomas Powles, MD, PhD, and colleagues found that maintenance treatment with avelumab plus best supportive care significantly improved overall survival vs best supportive care alone among patients whose...

Colorectal Cancer
Immunotherapy

Study Finds Disparities in Microsatellite Instability/Mismatch Repair Biomarker Testing for Patients With Stage IV Colorectal Cancer

Immune checkpoint inhibitors have improved outcomes for patients with a variety of cancer types, including those with advanced colorectal cancers that test positive for microsatellite instability/mismatch repair deficiency (MSI-high/MMRd). While testing rates for patients with MSI-high/MMRd...

Lung Cancer
Immunotherapy

First-Line Atezolizumab vs Chemotherapy in PD-L1–Positive Metastatic NSCLC: IMpower110

As reported in The New England Journal of Medicine by Roy S. Herbst, MD, PhD, and colleagues, the phase III IMpower110 trial has shown significantly prolonged overall survival with first-line atezolizumab vs platinum-based chemotherapy in patients with metastatic non–small cell lung cancer (NSCLC)...

Leukemia
Immunotherapy

Four-Year Findings From the MURANO Trial: Venetoclax Plus Rituximab for Relapsed Chronic Lymphocytic Leukemia

As reported in the Journal of Clinical Oncology by Kater et al, 4-year progression-free and overall survival were significantly greater with venetoclax plus rituximab vs bendamustine plus rituximab in the phase III MURANO trial in patients with relapsed or refractory chronic lymphocytic leukemia....

Lung Cancer
Immunotherapy

FDA Approves Nivolumab Plus Ipilimumab for the First-Line Treatment of Unresectable Malignant Pleural Mesothelioma

On October 2, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) as first-line treatment for adult patients with unresectable malignant pleural mesothelioma. CheckMate 743 Efficacy was investigated in CheckMate 743, a randomized,...

skin cancer
immunotherapy

Jeffrey S. Weber, MD, PhD, on Melanoma: Adjuvant Nivolumab vs Ipilimumab

Jeffrey S. Weber, MD, PhD, of the Perlmutter Cancer Center, NYU Langone, discusses the 4-year recurrence-free and overall survival results from the CheckMate 238 study, which showed adjuvant nivolumab continues to be an effective treatment, vs the comparator ipilimumab, for patients with resected stage III/IV melanoma (Abstract 1076O).

Breast Cancer
Immunotherapy

Expert Point of View: Lisa A. Carey, MD

Invited study discussant Lisa A. Carey, MD, the Richardson and Marilyn Jacobs Preyer Distinguished Professor in Breast Cancer Research and Deputy Director of Clinical Sciences at the University of North Carolina-Chapel Hill, framed her remarks as a tale of two trials. Dr. Carey asked these...

Breast Cancer
Immunotherapy

IMpassion131: No Benefit for Atezolizumab Plus Paclitaxel in Triple-Negative Breast Cancer

Based on some unexpected negative results, oncologists using atezolizumab for metastatic triple-negative breast cancer should pair it with nab-paclitaxel, not paclitaxel. In contrast to the overall survival benefit shown for atezolizumab plus nab-paclitaxel in the previous IMpassion130...

Immunotherapy
Multiple Myeloma
Lymphoma
Gastroesophageal Cancer
Gastrointestinal Cancer
Breast Cancer

FDA Pipeline: Priority Review for Agents in Multiple Myeloma, Anaplastic Large Cell Lymphoma

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to therapies for pretreated patients with multiple myeloma and pediatric patients with ALK-positive anaplastic large cell lymphoma; granted Fast Track designation to novel agents in gastric/gastroesophageal junction...

Skin Cancer
Immunotherapy

Four-Year Outcomes in CheckMate 238: Adjuvant Nivolumab vs Ipilimumab in Stage IIIB–IIIC or IV Melanoma

As reported in The Lancet Oncology by Paolo A. Ascierto, MD, and colleagues, 4-year results of the CheckMate 238 trial show the continued benefit of adjuvant nivolumab vs ipilimumab in recurrence-free and metastasis-free survival in patients with resected stage IIIB–IIIC or IV melanoma, with no...

Bladder Cancer
Immunotherapy

First-Line Durvalumab With or Without Tremelimumab vs Chemotherapy for Metastatic Urothelial Carcinoma

In the phase III DANUBE trial, reported in The Lancet Oncology, Thomas Powles, MD, PhD, and colleagues found that durvalumab monotherapy did not prolong overall survival vs standard chemotherapy in previously untreated patients with largely metastatic urothelial carcinoma with high PD-L1...

Breast Cancer
Immunotherapy

Addition of Atezolizumab to Neoadjuvant Chemotherapy in Early-Stage Triple-Negative Breast Cancer: IMpassion031 Trial

As reported in The Lancet by Elizabeth A. Mittendorf, MD, and colleagues, results from the phase III IMpassion031 trial showed improved pathologic complete response rates with the addition of atezolizumab to sequential nab-paclitaxel and anthracycline-based neoadjuvant chemotherapy in patients with ...

breast cancer
immunotherapy

Lisa A. Carey, MD, on Triple-Negative Breast Cancer: Paclitaxel, Nab-paclitaxel, and Atezolizumab in IMpassion Trials

Lisa A. Carey, MD, of the University of North Carolina, discusses phase III results from two IMpassion trials, 130 and 131, which explored, respectively, atezolizumab plus nab-paclitaxel vs placebo plus nab-paclitaxel in previously untreated locally advanced or metastatic triple-negative breast cancer and first-line paclitaxel with or without atezolizumab for unresectable disease (Abstracts LBA15 and LBA16).

Solid Tumors
Immunotherapy

First-in-Class Human IgG4 Monoclonal Antibody Shows Activity Alone and Combined With Pembrolizumab in Advanced Solid Tumors

MK-4830—a novel, first-in-class human IgG4 monoclonal antibody targeting the myeloid-specific anti–immunoglobulin-like transcript 4 (ILT4) receptor—administered either as a single agent or in combination with pembrolizumab was well tolerated and showed activity in heavily pretreated patients with...

Solid Tumors
Immunotherapy

Addition of Immunotherapy to Other Treatments in Patients With Brain Metastases After Definitive Surgery

In a National Cancer Database analysis reported in JAMA Network Open, Amin et al found that among patients with brain metastases who underwent definitive surgery for primary tumors, the combination of immunotherapy and radiotherapy prolonged overall survival compared with radiotherapy alone. Study...

Skin Cancer
Immunotherapy

Benefit of Pembrolizumab in High-Risk Stage III Melanoma: 3-Year Follow-up

As reported in the Journal of Clinical Oncology by Alexander M.M. Eggermont, MD, PhD, and colleagues, adjuvant pembrolizumab maintained a significant recurrence-free survival benefit vs placebo in patients with high-risk stage III melanoma after a median 3-year follow-up in the phase III EORTC...

skin cancer
immunotherapy

Alexander M. Eggermont, MD, PhD, on Melanoma: Pembrolizumab vs Placebo After Complete Resection

Alexander M. Eggermont, MD, PhD, of the Princess Maxima Center for Pediatric Oncology, discusses final results of the phase III EORTC 1325-MG/Keynote 054 trial, which confirmed a sustained recurrence-free survival benefit of pembrolizumab vs placebo in patients with resected high-risk stage III melanoma, as well as a decrease in the incidence of distant and locoregional recurrence (Abstract LBA46).

breast cancer
immunotherapy

Aditya Bardia, MD, MPH, on Triple-Negative Breast Cancer: Sacituzumab Govitecan vs Treatment of Physician’s Choice

Aditya Bardia, MD, MPH, of Massachusetts General Hospital Cancer Center, discusses results from the phase III ASCENT trial, which showed the antibody-drug conjugate sacituzumab govitecan-hziy improved progression-free and overall survival more than standard single-agent chemotherapy in patients with previously treated metastatic triple-negative breast cancer (Abstract LBA17).

Sarcoma
Immunotherapy

Does Pembrolizumab Monotherapy Demonstrate Benefit in Rare Sarcomas?

Pembrolizumab monotherapy induced responses in patients with rare sarcomas that varied by histotype, according to findings presented by Jean-Yves Blay, MD, at the ESMO Virtual Congress 2020 (Abstract 1619O). Methods Dr. Blay presented first results from a cohort of patients with rare sarcomas in...

Lymphoma
Immunotherapy

NCCN Adds Tafasitamab-cxix to Its Clinical Practice Guidelines in Oncology for B-Cell Lymphomas

MorphoSys and Incyte have announced that tafasita­mab-cxix, a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, has been included in the latest National Comprehensive Cancer Network Clinical Practice Guidelines®  (NCCN Guidelines®) in Oncology for B-Cell Lymphomas. Specifically,...

Lymphoma
Immunotherapy

Brexucabtagene Autoleucel for Relapsed or Refractory Mantle Cell Lymphoma

On July 24, 2020, brexucabtagene autoleucel, a CD19-directed genetically modified autologous T-cell immunotherapy, was granted accelerated approval for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.1,2 Brexucabtagene autoleucel is approved with a Risk Evaluation...

Multiple Myeloma
Immunotherapy

Updates on BCMA-Directed CAR-Modified T-Cell Gene Therapies

Outcomes in patients with triple-class–failure relapsed and refractory multiple myeloma who experience disease progression on immunomodulatory agents, proteasome inhibitors, and CD38 antibodies are dismal. Most recently, early results of three anti-B-cell maturation antigen (BCMA) chimeric antigen...

Breast Cancer
Immunotherapy

Phase III NALA Trial Meets Primary Endpoint in Previously Treated HER2-Positive Breast Cancer

As reported in the Journal of Clinical Oncology by Cristina Saura, MD, of Vall d’Hebron University Hospital, Barcelona, and colleagues, the phase III NALA trial has shown significantly prolonged progression-free survival with the irreversible pan-HER tyrosine kinase inhibitor neratinib plus...

Lymphoma
Immunotherapy

Newer Therapeutic Approaches Improving Outcomes in Hodgkin Lymphoma

At the 2020 Debates and Didactics in Hematology and Oncology Virtual Conference, sponsored by Emory University School of Medicine and Winship Cancer Institute, Pamela Allen, MD, Assistant Professor of Medicine at Emory, described recent trials on therapeutic approaches that are informative on this...

Immunotherapy

Meta-analyses of Quality of Life in Patients Treated With Checkpoint Inhibitors

Findings from two meta-analyses designed to summarize quality-of-life data on patients receiving immune checkpoint inhibitor therapy for cancer were presented at the ESMO Virtual Congress 2020 (Abstract 1568O). These meta-analyses found that patients receiving immune checkpoint inhibitors had...

Genomics/Genetics
Immunotherapy

Nivolumab Shows Activity in edPOLE-Mutated, MMR-Proficient Advanced Cancers

Nivolumab monotherapy showed high response and disease control rates in patients with pathogenic exonuclease domain POLE (edPOLE)-mutated, mismatch repair (MMR)-proficient advanced tumors containing confirmed pathogenic mutations, according to findings presented by Benoit J.C. Rousseau, MD, PhD, of ...

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