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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...

Multiple Myeloma
Immunotherapy

Surbhi Sidana, MD, Comments on CAR T-Cell Therapy and Bispecific Antibodies Targeting Myeloma

The session’s invited discussant Surbhi Sidana, MD, Assistant Professor of Medicine, Stanford University, said CAR T-cell therapy and bispecific antibodies targeting myeloma are emerging as potentially effective options for patients with highly refractory disease. For this population of triple...

Multiple Myeloma
Immunotherapy

Bispecific Antibodies Advance in Relapsed or Refractory Multiple Myeloma

For the challenging population of patients with multiple myeloma who have become refractory to essentially all current treatments, new approaches are much needed. Early clinical trials data suggest bispecific antibodies may help meet this need, as suggested by studies presented at the 2021 ASCO...

Skin Cancer
Immunotherapy

Pembrolizumab Shows Durable Antitumor Activity in Both Locally Advanced and Recurrent/Metastatic Squamous Cell Carcinomas

The results of the second interim analysis of the KEYNOTE-629 study of pembrolizumab in cutaneous squamous cell carcinoma confirmed durable antitumor activity in both the locally advanced and the recurrent/metastatic settings. Adverse events with pembrolizumab were generally consistent with its...

Breast Cancer
Immunotherapy

FDA Approves Pembrolizumab in Combination for High-Risk, Early-Stage Triple-Negative Breast Cancer

On July 26, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for high-risk, early-stage triple-negative breast cancer in combination with chemotherapy as a neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. The FDA also...

Immunotherapy
Skin Cancer

Benefits of Adjuvant Pembrolizumab in Melanoma Reinforced by EORTC 1325/KEYNOTE-054 Updates

Adjuvant anti–PD-1 antibody therapy is widely used for stage III melanoma, given the approvals of pembrolizumab and nivolumab. These approvals were based on significantly improved relapse-free survival in the CheckMate 238 trial of nivolumab compared with ipilimumab and the EORTC 1325/KEYNOTE-054...

Skin Cancer
Immunotherapy

Adjuvant Pembrolizumab Improves Distant Metastasis–Free Survival in Resected High-Risk Stage III Melanoma

As reported in The Lancet Oncology by Alexander M.M. Eggermont, MD, of Princess Máxima Center, Utrecht, the Netherlands, and colleagues, the pivotal phase III EORTC 1325/KEYNOTE-054 trial has shown significant improvement in the secondary endpoint of distant metastasis–free survival, as well as...

Gynecologic Cancers
Immunotherapy

Dostarlimab-gxly for Mismatch Repair–Deficient Recurrent or Advanced Endometrial Cancer

On April 22, 2021, the PD-1 inhibitor dostarlimab-gxly was granted accelerated approval for treatment of adults with mismatch repair–deficient recurrent or advanced endometrial cancer, as determined by a U.S. Food and Drug Administration (FDA)-approved test, that has progressed on or following a...

Lymphoma
Immunotherapy

Axicabtagene Ciloleucel for Relapsed or Refractory Follicular Lymphoma

On March 5, 2021, the CD19-directed genetically modified autologous T-cell immunotherapy axicabtagene ciloleucel was granted accelerated approval for treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.1,2 Axicabtagene ciloleucel is...

Lung Cancer
Immunotherapy

Addition of Ipilimumab to Nivolumab in Previously Treated, Immunotherapy-Naive Patients With Stage IV Squamous NSCLC

As reported in JAMA Oncology by Scott N. Gettinger, MD, and colleagues, the phase III Lung Cancer Master Protocol S1400I trial showed no improvement in overall survival with the addition of ipilimumab to nivolumab in previously treated, immune checkpoint inhibitor–naive patients with stage IV...

Gynecologic Cancers
Immunotherapy

Expert Point of View: Carol Aghajanian, MD

“The phase III ENGOT/GCIG study1 proved to be negative, with no advantage seen with the extension of bevacizumab treatment,” said the abstract’s invited discussant, Carol Aghajanian, MD, Chief of the Medical Gynecologic Oncology Service at Memorial Sloan Kettering Cancer Center, New York. Dr....

Gynecologic Cancers
Immunotherapy

Bevacizumab in Advanced Ovarian Cancer: Phase III Trial Finds More Is Not Better

In advanced ovarian cancer, the duration of maintenance bevacizumab should remain 15 months, according to the European multicenter phase III ENGOT/GCIG trial. These results were presented during the 2021 ASCO Annual Meeting by Jacobus Pfisterer, MD, PhD, of the AGO Study Group and Gynecologic...

Skin Cancer
Immunotherapy

Interleukin-2 Pathway Agonist Bempegaldesleukin Plus Nivolumab in the First-Line Treatment of Metastatic Melanoma

In the phase II cohort of a phase I/II trial (PIVOT-02) reported in the Journal of Clinical Oncology, Adi Diab, MD, and colleagues found that the combination of the interleukin-2 pathway agonist bempegaldesleukin and nivolumab produced high response rates and extended progression-free survival in...

Gynecologic Cancers
Immunotherapy

Pembrolizumab/Lenvatinib Granted Regular Approval for Advanced Endometrial Carcinoma

On July 21, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with lenvatinib (Lenvima) for patients with advanced endometrial carcinoma that is not microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR). These patients must have ...

Breast Cancer
Immunotherapy

Efficacy of Dendritic Cell Vaccines Plus Standard Therapy for Breast Cancer

A report published by Oba et al in the Journal for ImmunoTherapy of Cancer shares new data on combining standard treatment for breast cancer with a particular form of cancer immunotherapy—dendritic cell vaccines. The study is reportedly the first to demonstrate that in situ dendritic cell vaccines...

Sarcoma
Immunotherapy

Addition of Prime-Boost Vaccination Regimen to Atezolizumab in Soft-Tissue Sarcomas Expressing NY-ESO-1

In a phase II trial reported in the Journal of Clinical Oncology, Sant P. Chawla, MD, and colleagues found that the addition of the heterologous prime-boost vaccination regimen CMB305 to atezolizumab did not improve survival outcomes in patients with soft-tissue sarcomas expressing the...

Leukemia
Immunotherapy

Combination Ficlatuzumab and Cytarabine Show Clinical Activity in Relapsed/Refractory AML

Despite advances in the treatment of acute myeloid leukemia (AML), only 29.5% of patients with the cancer are alive 5 years after diagnosis. Even with aggressive therapy, just 30% of patients achieve a complete remission with a median survival of 7.5 months, making it imperative to develop novel...

Gastrointestinal Cancer
Immunotherapy

Atezolizumab Plus Bevacizumab in Malignant Peritoneal Mesothelioma

A phase II study published by Kanwal Raghav, MBBS, MD, and colleagues in Cancer Discovery found that combination treatment with the PD-L1 inhibitor atezolizumab and the VEGF inhibitor bevacizumab was well tolerated and resulted in a 40% objective response rate in patients with advanced malignant...

Lung Cancer
Immunotherapy

Adding Perioperative Durvalumab to Neoadjuvant Chemotherapy in Stage IIIA NSCLC

In a Swiss phase II trial (SAKK 16/14) reported in the Journal of Clinical Oncology, Rothschild et al found that the addition of perioperative durvalumab to neoadjuvant cisplatin/docetaxel resulted in a high major pathologic response rate and an event-free survival rate of 73% in patients with...

CNS Cancers
Immunotherapy

HER2-Specific CAR T-Cell Trial Addresses Pediatric Brain and Spinal Cord Tumors

Locoregional delivery of chimeric antigen receptor (CAR) T cells has resulted in objective responses in adults with glioblastoma, but the approach has not been evaluated in pediatric patients with brain and central nervous system tumors. The innovative, ongoing phase I BrainChild-01 trial is...

Breast Cancer
Immunotherapy

Real-World Survival Outcomes With Pertuzumab Plus T-DM1 for HER2-Positive Metastatic Breast Cancer

In a Canadian population-based retrospective cohort study reported in JAMA Oncology, Ethier et al identified real-world survival outcomes among women receiving pertuzumab and trastuzumab emtansine (T-DM1) for stage IV HER2-positive breast cancer, observing that outcomes appeared to be poorer than...

Breast Cancer
Immunotherapy

Evandro de Azambuja, MD, PhD, Discusses the Short-HER Trial

Invited discussant of the Short-HER trial, Evandro de Azambuja, MD, PhD, Head of the Medical Support Team at the Institut Jules Bordet, Brussels, acknowledged the good outcomes in low- and intermediate-risk patients treated with either a short or long duration of trastuzumab but said 1 year of the...

Breast Cancer
Immunotherapy

Long-Term Analysis of Short-HER Trial of Adjuvant Trastuzumab

Long-term analysis of the Short-HER trial showed that 9 weeks of adjuvant trastuzumab conveyed benefits comparable to a 1-year course in patients with early HER2-positive breast cancer deemed to be at low or intermediate risk for recurrence. High-risk patients, however, derived considerably more...

Immunotherapy
Skin Cancer

Study Identifies Gut Microbes Associated With Combination Immunotherapy Response and Adverse Events

Researchers have found that specific intestinal microbiota signatures may correlate with high-grade adverse events and response to combined CTLA-4 and PD-1 blockade treatment. The study, published by Andrews et al in Nature Medicine, also identified a potential new strategy to treat toxicity—while...

Gastrointestinal Cancer
Immunotherapy

DESTINY-Gastric01 Exploratory Biomarker Analysis Examines Efficacy of Trastuzumab Deruxtecan-nxki Among Patients With HER2-Positive and HER2-Low Gastric Cancer

Trastuzumab deruxtecan-nxki demonstrated clinically meaningful benefit across specific subgroups of patients with HER2-positive and HER2-low advanced gastric cancer, according to findings from a post hoc exploratory biomarker analysis presented by Kohei Shitara, MD, and colleagues at the ESMO World ...

lymphoma
immunotherapy

Martin H. Dreyling, MD, PhD, on Follicular Lymphoma: Safety and Efficacy of Tisagenlecleucel

Martin H. Dreyling, MD, PhD, of University Hospital Munich Grosshadern Klinikum, discusses phase II results from the ELARA trial, which suggests tisagenlecleucel may be a promising immunotherapy for adults with relapsed or refractory follicular lymphoma (Abstract S210).

Multiple Myeloma
Immunotherapy

FDA Approves Daratumumab and Hyaluronidase-fihj With Pomalidomide and Dexamethasone for Pretreated Patients With Multiple Myeloma

On July 9, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a...

Lung Cancer
Genomics/Genetics
Immunotherapy

Expert Point of View: Edward B. Garon, MD, MS

Invited discussant of the BOOSTER trial,1 Edward B. Garon, MD, MS, Professor of Medicine and Director of the Thoracic Oncology Program, David Geffen School of Medicine at the University of California Los Angeles, said the study’s research question is appropriate, since osimertinib was established...

Lung Cancer
Genomics/Genetics
Immunotherapy

Study Finds Bevacizumab Offers No Boost to Second-Line Osimertinib in EGFR T790M–Mutated Lung Cancer

For the second-line treatment of advanced EGFR T790M–mutated non–small cell lung cancer (NSCLC), the performance of osimertinib alone was not found to be different from that of osimertinib plus bevacizumab in the phase II ETOP 10-16 ­BOOSTER trial, reported at a European Society for Medical...

Lung Cancer
Genomics/Genetics
Immunotherapy

Expert Point of View: Nicolas Girard, MD, PhD

Invited discussant Nicolas Girard, MD, PhD, of the Curie Institute, Paris, said, “A major challenge in NSCLC is what happens when osimertinib resistance develops.” “A key takeaway point from this study is that the efficacy is driven by resistance mechanism. The overall response rate was 47% in the ...

Lung Cancer
Genomics/Genetics
Immunotherapy

Amivantamab/Lazertinib Combination May Overcome Osimertinib Resistance in Patients With EGFR-Positive NSCLC

Combination targeting of epidermal growth factor receptor (EGFR) with amivantamab/lazertinib achieved durable responses in more than one-third of chemotherapy-naive patients with EGFR-mutant non–small cell lung cancer (NSCLC) that had progressed on osimertinib, according to a cohort analysis of the ...

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