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Bladder Cancer
Immunotherapy

FDA Revises Label for Pembrolizumab in Patients With Advanced Urothelial Carcinoma

On August 31, the U.S. Food and Drug Administration (FDA) revised the label for the anti–PD-1 therapy pembrolizumab for its indication in first-line advanced urothelial carcinoma. The FDA converted the indication from an accelerated approval to a full approval. In addition, as part of the label...

Breast Cancer
Immunotherapy

Evandro de Azambuja, MD, PhD, Comments on the BERENICE Trial

The invited discussant for the BERENICE trial was Evandro de Azambuja, MD, PhD, Head of the Medical Support Team at the Institut Jules Bordet in Brussels. He concluded from the study that pertuzumab plus trastuzumab, combined with an anthracycline/taxane regimen given every 2 weeks or every 3...

Breast Cancer
Immunotherapy

Safety, Efficacy of Neoadjuvant Pertuzumab Plus Trastuzumab Maintained in Final Analysis of BERENICE Trial

Long-term cardiac safety and efficacy have been confirmed for pertuzu­mab plus trastuzumab in patients with early breast cancer, in an update of the phase II BERENICE trial reported at the 2021 ESMO Breast Cancer Virtual Congress.1 Chau T. Dang, MD, of the Breast Medicine Service at Memorial Sloan...

Gastroesophageal Cancer
Immunotherapy

Addition of Pembrolizumab to Chemotherapy for the First-Line Treatment of Advanced Esophageal Cancer: KEYNOTE-590

As reported in The Lancet by Sun et al, the phase III KEYNOTE-590 trial showed that the addition of first-line pembrolizumab to chemotherapy resulted in improved overall and progression-free survival in patients with advanced esophageal and Siewert type 1 gastroesophageal junction (GEJ) cancers....

Lung Cancer
Immunotherapy

Study Highlights Gaps Between Lung Cancer Treatment Recommendations and Real-World Use of Durvalumab

A recent study published by Ronden et al in JTO Clinical and Research Reports highlights the gap between treatment guidelines and real-world care with the monoclonal antibody durvalumab for patients with non–small cell lung cancer. Researchers studied treatment decision-making by three Dutch...

Breast Cancer
Immunotherapy

Update on U.S. Indication for Atezolizumab in PD-L1–Positive Metastatic Triple-Negative Breast Cancer

Genentech, a member of the Roche Group, announced that it has made the decision to voluntarily withdraw the U.S. accelerated approval for atezolizumab (Tecentriq) in combination with nab-paclitaxel for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast...

Immunotherapy

Profile of Adverse Events Related to PD-1 and PD-L1 Inhibitor–Based Therapy

In a systematic review and meta-analysis reported in The Lancet Oncology, Zhou et al provided a profile of treatment-related adverse events observed in clinical trials combining PD-1 or PD-L1 inhibitors with chemotherapy, targeted therapy, immunotherapy, and radiotherapy. Study Details The...

Breast Cancer
Immunotherapy

Sacituzumab Govitecan-hziy for Locally Advanced or Metastatic Triple-Negative Breast Cancer

On April 7, 2021, sacituzumab govitecan-hziy was granted regular approval for treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.1 Sacituzumab...

Bladder Cancer
Immunotherapy

Sacituzumab Govitecan-hziy for Locally Advanced or Metastatic Urothelial Cancer

On April 13, 2021, sacituzumab govitecan-hziy was granted accelerated approval to treat patients with locally advanced or metastatic urothelial cancer who had received platinum-containing chemotherapy and either a PD-1 or a PD-L1 inhibitor.1 Supporting Efficacy Data Approval was based on findings...

Hematologic Malignancies
Head and Neck Cancer
Gynecologic Cancers
Immunotherapy
Symptom Management

FDA Pipeline: Reviews for Agents in Acute Graft-vs-Host Disease, Nasopharyngeal and Ovarian Cancers

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to an agent for the prevention of acute graft-vs-host disease; Breakthrough Therapy designation to an anti–PD-1 monoclonal antibody for the treatment of metastatic nasopharyngeal carcinoma; and Fast Track designation to a ...

Skin Cancer
Immunotherapy

Patients With Melanoma Previously Treated With PD-1 or MAPK Inhibitors May Be Less Likely to Respond to ACT-TIL Therapy

Patients with metastatic melanoma who were previously treated with PD-1 or MAPK inhibition are significantly less likely to develop durable objective responses to adoptive cell transfer of tumor-infiltrating lymphocytes (ACT-TIL) than patients naive to these treatments, according to a study...

Kidney Cancer
Immunotherapy

Adjuvant Pembrolizumab May Improve Disease-Free Survival in Patients With High-Risk Renal Cell Carcinoma

As reported in The New England Journal of Medicine by Toni K. Choueiri, MD, and colleagues, an interim analysis of the phase III KEYNOTE-564 trial showed improved disease-free survival with adjuvant pembrolizumab vs placebo after nephrectomy in high-risk patients with clear cell renal cell...

Bladder Cancer
Immunotherapy

FDA Approves Nivolumab for Adjuvant Treatment of Urothelial Carcinoma

On August 19, the U.S. Food and Drug Administration (FDA) approved the anti–PD-1 therapy nivolumab (Opdivo) for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of disease recurrence after undergoing radical resection. This is the first FDA approval for adjuvant...

Leukemia
Immunotherapy

Outcomes Notably Improving for Adult ALL

Outcomes in adults with acute lymphoblastic leukemia (ALL) are almost rivaling those in pediatric ALL, thanks to the benefits achieved by incorporating blinatumomab and inotuzumab into chemotherapy regimens. New ways of administering the chemotherapy component are also increasing tolerability and...

Lung Cancer
Immunotherapy

Does Antibiotic Exposure Affect Response to First-Line Chemoimmunotherapy in Patients With NSCLC?

In an international, multicenter study, researchers evaluated the impact of prior and concurrent antibiotic exposure in a cohort of patients with advanced non–small cell lung cancer (NSCLC) treated with first-line chemoimmunotherapy combinations. In contrast to what has been reported in patients...

Colorectal Cancer
Genomics/Genetics
Immunotherapy

Cetuximab Plus Avelumab as Rechallenge Therapy for RAS Wild-Type Metastatic Colorectal Cancer

In an Italian phase II trial reported in JAMA Oncology, Martinelli et al found that cetuximab rechallenge plus avelumab showed activity and was well tolerated in patients with RAS wild-type metastatic colorectal cancer who had responded to first-line chemotherapy plus an anti-EGFR agent and then...

Colorectal Cancer
Immunotherapy

Eric Deutsch, MD, PhD, Comments on the Averectal and AVANA Trials in Rectal Cancer

Eric Deutsch, MD, PhD, Professor and Chair of Radiation Oncology at Gustave Roussy, Villejuif, France, commended the speakers for conducting trials whose results he found “very interesting.” The Averectal trial involved a short course of radiation with modified FOLFOX-6 (oxaliplatin, fluorouracil...

Colorectal Cancer
Immunotherapy

Avelumab Under Study as Adjunct to Neoadjuvant Therapy for Rectal Cancer

In the treatment of newly diagnosed locally advanced rectal cancer, two phase II studies evaluating the addition of the PD-L1 inhibitor avelumab to chemoradiotherapy showed promising rates of pathologic complete response, major pathologic response, and tumor downstaging. The study investigators...

Leukemia
Immunotherapy

Donor-Derived CD7 CAR T Cells May Lead to Remissions in Patients With Relapsed or Refractory T-ALL

In a Chinese single-institution phase I study reported in the Journal of Clinical Oncology, Pan et al found that donor-derived CD7 chimeric antigen receptor (CAR) T-cell therapy produced a high complete remission rate in patients with relapsed or refractory T-cell acute lymphoblastic leukemia...

Leukemia
Immunotherapy

Experimental Small-Molecule Inhibitor May Improve Responses to Cellular Therapies in Advanced CLL

Too many “exhausted” T cells left in the wake of aggressive chemotherapy regimens for patients with advanced chronic lymphocytic leukemia (CLL) make it more challenging for chimeric antigen receptor (CAR) T-cell therapy to do its job. Now, a new study from researchers at the Perelman School of...

Solid Tumors
Immunotherapy

FDA Grants Accelerated Approval to Dostarlimab-gxly for dMMR Advanced Solid Tumors

On August 17, the U.S. Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly (Jemperli), an anti–PD-1 antibody, for adult patients with mismatch repair–deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, who have had disease...

Breast Cancer
Immunotherapy

Study Identifies Potential Mechanisms of Resistance to Sacituzumab Govitecan-hziy in Patients With Triple-Negative Breast Cancer

Researchers have determined how a highly aggressive type of breast cancer may evade treatment with the compound sacituzumab govitecan-hziy, according to findings published by Coates et al in Cancer Discovery. Their results could help improve therapy and ultimately prolong survival for patients with ...

Sarcoma
Immunotherapy

Small Study Evaluates Combination Ipilimumab/Nivolumab in Patients With Angiosarcoma

In a small study of 16 patients with angiosarcoma published by Michael Wagner, MD, and colleagues in the Journal for ImmunoTherapy of Cancer, 4 patients experienced a partial or complete response to treatment with a combination of the immunotherapies ipilimumab and nivolumab, and another 2 patients ...

lymphoma
immunotherapy

Steven M. Horwitz, MD, on Advanced-Stage Mycosis Fungoides and Sezary Syndrome: Update on Management Practices

Steven M. Horwitz, MD, of Memorial Sloan Kettering Cancer Center, discusses treatments for advanced mycosis fungoides and Sezary syndrome, including brentuximab vedotin and mogamulizumab, and how best to choose among treatments.

lymphoma
immunotherapy

James O. Armitage, MD, on Advanced Hodgkin Lymphoma: Choosing Among BEACOPP, A-AVD, and Checkpoint Inhibitors

James O. Armitage, MD, of the University of Nebraska Medical Center, discusses various treatment regimens for patients with Hodgkin lymphoma, including BEACOPP, brentuximab vedotin, ABVD, A-AVD, nivolumab, and pembrolizumab—and the factors to consider when choosing among them.

lymphoma
immunotherapy

Bruce D. Cheson, MD, and Stephen M. Ansell, MD, PhD, on Non-Hodgkin and Follicular Lymphomas: Integrating Non–CAR T-Based Treatments

Stephen M. Ansell, MD, PhD, of the Mayo Clinic, and Bruce D. Cheson, MD, of the Lymphoma Research Foundation, engage in a lively debate about CAR T-cell therapy, how it fits in with immunotherapy and nonchemotherapy approaches, and how to decide which treatment is right for which patient, especially given the many challenges of obtaining CAR T cells.

lymphoma
immunotherapy

Alison J. Moskowitz, MD, on ABVD in Hodgkin Lymphoma: Adding Brentuximab Vedotin and Checkpoint Inhibitors to Standard Treatment

Alison J. Moskowitz, MD, of Memorial Sloan Kettering Cancer Center, discusses the combination ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine), individualized approaches for treating patients with Hodgkin lymphoma, and novel methods for risk stratification.

hematologic malignancies
leukemia
immunotherapy

Alexey V. Danilov, MD, PhD, on Lymphoid Malignancies: Novel Agents Targeting BTK Inhibitor–Resistant Disease

Alexey V. Danilov, MD, PhD, of City of Hope, discusses the uses and side effects of cellular and immune therapies, including venetoclax and obinutuzumab, which may prove to be effective in treating highly resistant lymphoid malignancies such as chronic lymphocytic leukemia.

Multiple Myeloma
Immunotherapy

Teclistamab Shows Efficacy, Produces Durable Responses in Relapsed or Refractory Multiple Myeloma

In a phase I trial (MajesTEC-1) reported in The Lancet, Saad Z. Usmani, MD, FACP, and colleagues found that the B-cell maturation antigen (BCMA)-CD3 bispecific antibody teclistamab produced a high rate of durable responses at the recommended phase II dose in patients with relapsed or refractory...

Breast Cancer
Immunotherapy

Meta-analysis of Outcomes With the Addition of Adjuvant Trastuzumab to Chemotherapy for HER2-Positive Breast Cancer

In a study conducted by the Early Breast Cancer Trialists’ Collaborative Group and reported in The Lancet Oncology by Bradley et al, an individual patient data meta-analysis of randomized trials has shown that the addition of adjuvant trastuzumab to chemotherapy reduces the risk of disease...

Pancreatic Cancer
Immunotherapy

Tackling the Challenge of Pancreatic Cancer: New Approaches

Pancreatic cancer remains an incorrigible foe, but recent advances in genomic profiling and targeted drug development are slowly improving the outlook for patients, according to Eileen M. O’Reilly, MD, Winthrop Rockefeller Endowed Chair in Medical Oncology and Section Head,...

Leukemia
Skin Cancer
Gynecologic Cancers
Kidney Cancer
Lung Cancer
Thyroid Cancer
Immunotherapy

FDA Pipeline: Reviews for Agents in Lung Cancer, Thyroid Cancer, Kidney Cancer, and More

Recently, the U.S. Food and Drug Administration (FDA) accepted applications for agents aiming to treat non–small cell lung cancer (NSCLC), differentiated thyroid cancer, renal cell carcinoma (RCC), hypersensitive acute lymphoblastic leukemia (ALL), mucosal melanoma, and endometrial carcinoma....

Kidney Cancer
Immunotherapy

FDA Approves Lenvatinib/Pembrolizumab for Advanced Renal Cell Carcinoma

On August 10, the U.S. Food and Drug Administration (FDA) approved the combination of lenvatinib (Lenvima) plus pembrolizumab (Keytruda) for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). CLEAR Trial The efficacy of this combination was investigated in CLEAR...

hematologic malignancies
immunotherapy
global cancer care

Peihua (Peggy) Lu, MD, on CAR T-Cell Therapy: Research in China

Peihua Lu, MD, of Lu Daopei Hospital, discusses the state of research in China on CAR T-cell therapy, placing it in the context of the global development pipeline and the progress being made.

Gynecologic Cancers
Immunotherapy

Addition of Avelumab to Chemotherapy in Previously Untreated Patients With Advanced Epithelial Ovarian Cancer: JAVELIN Ovarian 100 Trial

As reported by Bradley J. Monk, MD, and colleagues in The Lancet Oncology, the phase III JAVELIN Ovarian 100 trial showed no progression-free survival benefit with the addition of concurrent and/or maintenance avelumab to chemotherapy in previously untreated patients with advanced epithelial...

Head and Neck Cancer
Immunotherapy

JAVELIN Head and Neck 100 Trial: When Failure Seems Fatal, Hope Is Not Lost

Data from KEYNOTE-048 showed that the combination of the checkpoint inhibitor pembrolizumab with platinum-containing therapy improved overall survival vs cetuximab plus chemotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).1 The findings provided hope...

Head and Neck Cancer
Immunotherapy

No Progression-Free Survival Benefit With First-Line Avelumab Plus Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck

As reported in The Lancet Oncology by Nancy Y. Lee, MD, of Memorial Sloan Kettering Cancer Center, and colleagues, the phase III JAVELIN Head and Neck 100 trial has shown no improvement in progression-free survival with the addition of the PD-L1 inhibitor avelumab to chemoradiotherapy in patients...

Breast Cancer
Immunotherapy

Expert Point of View: Melinda L. Telli, MD

The invited discussant of GeparNuevo,1 Melinda L. Telli, MD, Associate Professor of Medicine at Stanford University School of Medicine, Director of the Breast Cancer Program at the Stanford Cancer Institute, and Associate Director of the Stanford Women’s Cancer Center, welcomed the additional data...

Breast Cancer
Immunotherapy

Neoadjuvant Durvalumab Improves Long-Term Outcomes in the GeparNuevo Trial

In the phase II GeparNuevo trial, patients with early triple-negative breast cancer receiving the PD-L1 inhibitor durvalumab in addition to chemotherapy as neoadjuvant therapy saw improvements in long-term outcomes. The results were presented at the 2021 ASCO Annual Meeting by Sibylle Loibl, MD,...

Lymphoma
Immunotherapy

Expert Point of View: Leslie Popplewell, MD

“Naratuximab emtansine plus rituximab appears to be an effective and well tolerated combination in a heavily pretreated population. The results of the study are very promising,” said Leslie Popplewell, MD, Associate Clinical Professor, Department of Hematology and Hematopoietic Cell...

Gastroesophageal Cancer
Immunotherapy

Expert Point of View: Kei Muro, MD, PhD

The RATIONALE 302 trial1 was discussed by Kei Muro, MD, PhD, of Aichi Cancer Center Hospital in Nagoya, Japan, who found the results promising. However, Dr. Muro questioned the role of PD-1/L1 inhibitors as second-line therapy for advanced esophageal squamous cell carcinoma. RATIONALE 302 is the...

Gastroesophageal Cancer
Immunotherapy

RATIONALE 302: Tislelizumab Improves Overall Survival as Second-Line Treatment of Esophageal Cancer

In the phase III RATIONALE 302 trial, the novel anti–PD-1 antibody tislelizumab, being developed in China, improved overall survival vs chemotherapy as second-line therapy for esophageal squamous cell carcinoma, according to Jaffer Ajani, MD, of The University of Houston MD Anderson Cancer Center,...

Bladder Cancer
Immunotherapy

Adjuvant Nivolumab Improves Disease-Free Survival in High-Risk Muscle-Invasive Urothelial Carcinoma

As reported in The New England Journal of Medicine by Dean F. Bajorin, MD, of the Department of Medicine, Memorial Sloan Kettering Cancer Center, and colleagues, an interim analysis of the phase III CheckMate 274 trial has shown improved disease-free survival with adjuvant nivolumab vs placebo...

Hepatobiliary Cancer
Immunotherapy

Pertuzumab and Trastuzumab in Previously Treated Patients With HER2-Positive Metastatic Biliary Tract Cancer

As reported in The Lancet Oncology by Milind Javle, MD, and colleagues, findings in a cohort of the phase IIa MyPathway multiple basket study showed that the combination of pertuzumab and trastuzumab produced responses in some previously treated patients with HER2-positive metastatic biliary tract...

Breast Cancer
Immunotherapy

A New Era of Hope for Patients With Triple-Negative Breast Cancer

Triple-negative breast cancer is a particularly devastating subtype of breast cancer, as it is often diagnosed in young women and is associated with an exceptionally poor prognosis. The “triple-negative” designation indicates that the three key features driving most breast cancers (estrogen...

Immunotherapy
Bladder Cancer

Is Disease-Free Survival the Best Endpoint for Adjuvant Nivolumab in High-Risk, Muscle-Invasive Urothelial Carcinoma?

The role of adjuvant treatment for invasive, high-grade bladder cancer remains controversial and challenging. Sternberg et al reported a statistically significant progression-free survival benefit from adjuvant combination gemcitabine/cisplatin (GC) or MVAC (methotrexate, vinblastine, doxorubicin, ...

Immunotherapy
Bladder Cancer

Adjuvant Nivolumab Improves Disease-Free Survival in High-Risk Muscle-Invasive Urothelial Carcinoma

As reported inThe New England Journal of Medicine by Dean F. Bajorin, MD, of the Department of Medicine, Memorial Sloan Kettering Cancer Center, and colleagues, an interim analysis of the phase III CheckMate 274 trial has shown improved disease-free survival with adjuvant nivolumab vs placebo...

Immunotherapy
Gastrointestinal Cancer

RATIONALE 208: ‘Durable Clinical Activity’ Reported With Tislelizumab in Advanced Liver Cancer

With the investigational checkpoint inhibitor tislelizumab, durable responses were achieved by some patients with previously treated advanced hepatocellular carcinoma, regardless of the number of prior lines of therapy, in the phase II RATIONALE 208 trial. These findings were presented during the...

Hepatobiliary Cancer
Immunotherapy

Tremelimumab, Durvalumab, or Both in Unresectable Hepatocellular Carcinoma

In a randomized expansion phase of a phase I/II study reported in the Journal of Clinical Oncology, Robin Kate Kelley, MD, and colleagues found that a novel regimen consisting of a single priming dose of tremelimumab in combination with durvalumab was associated with good outcomes in patients with...

Hepatobiliary Cancer
Immunotherapy

Neoadjuvant Cabozantinib/Nivolumab May Make Resection Possible for Some Patients With Liver Cancer

A combination of the kinase inhibitor cabozantinib and the immunotherapy nivolumab may make curative surgery possible for some patients with liver cancer who would generally not be considered candidates for surgery, according to research published by Ho et al in Nature Cancer. Rates of Resection...

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