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Lung Cancer
Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

FDA Pipeline: Priority Reviews in NSCLC, Gastric Cancer

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to a PD-1 inhibitor for the treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC), and also granted Priority Review to a HER2-directed antibody-drug conjugate for patients with...

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....

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...

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...

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...

Gastroesophageal Cancer
Immunotherapy

First-Line Checkpoint Inhibitors May Improve Survival in Gastroesophageal Cancers

Immune therapy for advanced gastroesophageal cancer has taken a leap forward by showing its value in the first-line setting, according to two studies in which nivolumab and pembrolizumab, both given with chemotherapy, significantly improved overall survival vs chemotherapy alone. The studies,...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

First-Line PD-1 Inhibitor With or Without Chemotherapy vs Chemotherapy Alone in Advanced Gastric Cancer: KEYNOTE-062

As reported in JAMA Oncology by Kohei Shitara, MD, and colleagues, the phase III KEYNOTE-062 trial showed no significant improvement in overall or progression-free survival with first-line pembrolizumab with or without chemotherapy vs chemotherapy alone in patients with PD-L1–positive advanced...

COVID-19
Breast Cancer
Colorectal Cancer
Gastroesophageal Cancer
Lung Cancer

Modeling Study Aims to Estimate the Effect of the COVID-19 Pandemic on Cancer Deaths in England

In a population-based modeling study reported in The Lancet Oncology, Maringe et al estimated that delays in diagnosis due to the COVID-19 pandemic could result in 3,291 to 3,621 additional deaths from breast, colorectal, esophageal, and lung cancers within 5 years. As stated by the investigators,...

Gastroesophageal Cancer
Immunotherapy

Nivolumab in Previously Treated Esophageal Squamous Cell Carcinoma

On June 10, 2020, nivolumab was approved for treatment of patients with unresectable, advanced, recurrent, or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy.1,2 Supporting Efficacy Data Approval was based on findings from the open-label,...

Gastroesophageal Cancer
Immunotherapy

Margetuximab/Pembrolizumab for Previously Treated Patients With HER2-Positive Advanced Gastroesophageal Adenocarcinoma

In a phase Ib/II trial reported in The Lancet Oncology, Daniel V.T. Catenacci, MD, and colleagues found that the combination of margetuximab and the anti–PD-1 therapy pembrolizumab showed evidence of activity in patients with previously treated HER2-positive gastroesophageal adenocarcinoma. As...

Gastroesophageal Cancer
Issues in Oncology

Study Finds Racial Disparities in Esophageal Cancer Surgical Rates

A new study published by Savitch et al in the Journal of Gastrointestinal Surgery found that black patients are less likely to receive surgery for resectable esophageal cancer, which may contribute to higher rates of death. “National guidelines suggest that early-stage esophageal cancer should be...

Colorectal Cancer
Pancreatic Cancer
Lymphoma
Hematologic Malignancies
Kidney Cancer
Gastroesophageal Cancer
Gastrointestinal Cancer

FDA Pipeline: Fast Track Designations in Colorectal and Pancreatic Cancers, Lymphoplasmacytic Lymphoma/Waldenström’s Macroglobulinemia

Over the past month, the U.S. Food and Drug Administration has granted Fast Track designation to agents designed to treat colorectal and pancreatic cancers, in addition to lymphoplasmacytic lymphoma/Waldenström’s macroglobulinemia; accepted a new drug application for a treatment for relapsed or...

Gastroesophageal Cancer
Immunotherapy

FDA Approves Nivolumab for Pretreated Patients With Esophageal Squamous Cell Carcinoma

On June 10, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) for patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy. ATTRACTION-3 Efficacy was investigated in...

Gastroesophageal Cancer

Outcomes With Minimally Invasive vs Open Esophagectomy in Routine Practice

In a Dutch study reported in the Journal of Clinical Oncology, Markar et al found that routine use of minimally invasive vs open esophagectomy for esophageal cancer was associated with increased risk of pulmonary complications and other adverse outcomes, contrary to the findings of the clinical...

Gastroesophageal Cancer
Immunotherapy

Pembrolizumab, Trastuzumab, and Chemotherapy in HER2-Positive Metastatic Esophagogastric Cancer

In a single-center phase II trial reported in The Lancet Oncology, Janjigian et al found that the addition of pembrolizumab to trastuzumab and chemotherapy showed activity in the first-line treatment of HER2-positive metastatic esophagogastric cancer. Study Details The investigator-initiated trial...

Gastroesophageal Cancer
Issues in Oncology

Do Marital Status and Race Affect the Treatment of Esophageal Cancer?

A study using data from the Michigan state cancer registry, reported in JCO Oncology Practice by Paniagua Cruz et al, found that a higher proportion of white vs black patients with esophageal cancer were married; that single patients were less likely to receive esophagectomy and chemotherapy; and...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

Trastuzumab Beyond Disease Progression in HER2‑Positive Advanced Gastric/Gastroesophageal Junction Cancer

In the Japanese phase II T-ACT study reported in the Journal of Clinical Oncology, Makiyama et al found no benefit of continued trastuzumab combined with paclitaxel after disease progression on first-line trastuzumab plus fluoropyrimidine/platinum chemotherapy in patients with HER2-positive...

Gastroesophageal Cancer
Immunotherapy

Bemarituzumab for FGFR2b-Overexpressing Gastroesophageal Adenocarcinoma

In a phase I trial reported in the Journal of Clinical Oncology, Daniel V.T. Catenacci, MD, PhD, and colleagues found that the first-in-class anti–fibroblast growth factor receptor 2b (FGFR2b) antibody bemarituzumab showed activity in patients with high FGFR2b-overexpressing, advanced-stage...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

Phase III JAVELIN Gastric 100 Trial Finds No Survival Benefit for Maintenance Avelumab

In the phase III JAVELIN Gastric 100 trial, a strategy called “switch maintenance” with the immune checkpoint inhibitor avelumab after 12 weeks of first-line induction chemotherapy did not statistically improve overall survival for treatment-naive patients with HER2-negative advanced gastric or...

Immunotherapy
Gastroesophageal Cancer
Gastrointestinal Cancer

Expert Point of View: Daniel V.T. Catenacci, MD

The analysis by Chao et al “highlights how well patients with MSI-H tumors do, compared to microsatellite-stable patients, and how much better they do in a randomized setting, being exposed to immunotherapy as compared to standard-of-care chemotherapy…The data also show that this is a...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

Pembrolizumab in MSI-H and CPS ≥ 10 Advanced Gastric or Gastroesophageal Junction Cancer: Subanalysis of KEYNOTE-059, -061, and -062

The survival benefit of pembrolizumab in advanced gastric/gastroesophageal junction cancer with microsatellite instability–high (MSI-H) tumors or a combined positive score (CPS) ≥ 10 was established in post hoc subanalysis of three KEYNOTE trials. Findings were presented at the 2020...

Gastroesophageal Cancer
Gastrointestinal Cancer
Colorectal Cancer
Hepatobiliary Cancer
Pancreatic Cancer

Conference Highlights From the 2020 Gastrointestinal Cancers Symposium

This past January, the 2020 Gastrointestinal Cancers Symposium was held in San Francisco. More than 3,600 individuals attended and more than 900 abstracts and posters were presented. Among the highlights presented at the meeting and reported in the pages of The ASCO Post, several studies in...

Gastroesophageal Cancer

Proton Beam Therapy vs Intensity-Modulated Radiation Therapy for Locally Advanced Esophageal Cancer

In a single-institution phase IIb trial reported in the Journal of Clinical Oncology, Steven H. Lin, MD, PhD, and colleagues found that proton beam therapy was associated with less toxicity and similar progression-free survival vs intensity-modulated radiation therapy in patients with locally...

Immunotherapy
Gastroesophageal Cancer
Gastrointestinal Cancer

Expert Point of View: Daniel V.T. Catenacci, MD

Daniel V.T. Catenacci, MD, of the University of Chicago Medical Center and Biological Sciences, emphasized the value of the patient having microsatellite instability–high (MSI-H) status as a biomarker for immunotherapy. The analysis by Chao et al “highlights how well patients with MSI-H tumors do,...

Immunotherapy
Gastroesophageal Cancer
Gastrointestinal Cancer

Survival Benefits Achieved With Pembrolizumab in MSI-H and CPS ≥ 10 Gastric/Gastroesophageal Junction Cancer

Post hoc subanalyses of three KEYNOTE trials established the survival benefit of pembrolizumab in advanced gastric/gastroesophageal junction cancer with microsatellite instability–high (MSI-H) tumors or a programmed cell death ligand 1 (PD-L1) combined positive score (CPS) ≥ 10 (ie, the number of...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

Expert Point of View: Daniel V.T. Catenacci, MD

Daniel V.T. Catenacci, MD, Associate Professor of Medicine and Director of the Gastrointestinal Oncology Program at the University of Chicago, was the JAVELIN Gastric 100 study’s invited discussant. After offering an extensive background on the use of immunotherapy in gastric or gastroesophageal...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

No Survival Benefit for Maintenance Avelumab in Advanced Gastric or Gastroesophageal Junction Cancer

In the phase III JAVELIN Gastric 100 trial, a strategy called “switch maintenance” with the immune checkpoint inhibitor avelumab after 12 weeks of first-line induction chemotherapy did not statistically improve overall survival for treatment-naive patients with HER2-negative advanced gastric or...

Lung Cancer
Lymphoma
Bladder Cancer
Head and Neck Cancer
Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

FDA Pipeline: Priority Reviews in Lung Cancers, Lymphoma

This week, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for non–small cell and small cell lung cancers, as well as for diffuse large-B cell lymphoma (DLBCL); Breakthrough Therapy designation to an antibody-drug conjugate for bladder cancer; and a double Fast...

Gastroesophageal Cancer

Expert Point of View: Marcia Cruz-Correa, MD, PhD

Marcia Cruz-Correa, MD, PhD, Professor of Medicine at the University of Puerto Rico and Adjunct Professor of Surgical Oncology at The University of Texas MD Anderson Cancer Center, congratulated the investigators on the conduct of the PANGEA trial and the outcomes it achieved for patients. “When...

Gastroesophageal Cancer

PANGEA Trial Shows Personalized Antibody Selection May Improve Outcomes in Gastroesophageal Cancer

A personalized approach to selecting antibody therapy for patients with newly diagnosed stage IV gastroesophageal adenocarcinoma resulted in a 1-year overall survival rate of 66% and a median overall survival of 16.4 months in the PANGEA study (see Table 1).1 The study used a novel clinical...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Zev A. Wainberg, MD, on PD-L1­–Positive Advanced Gastric Cancer: MSI and Combined Positive Score and Pembrolizumab vs Chemotherapy

Zev A. Wainberg, MD, of the UCLA Medical Center, discusses the first subset analysis of how a combined positive score in gastric and gastroesophageal junction cancers related to the efficacy of pembrolizumab in PD-L1–positive disease (Abstract 427).

Gastroesophageal Cancer
Genomics/Genetics

Treatment of Advanced Esophagogastric Cancer According to ERCC1 Expression

As reported in the Journal of Clinical Oncology by Iqbal and colleagues, the phase II SWOG S1201 trial showed a progression-free survival benefit with platinum-containing vs nonplatinum treatment among all patients with previously untreated HER2-negative advanced esophagogastric cancer and in a...

Gastroesophageal Cancer
Gastrointestinal Cancer

Trifluridine/Tipiracil in Recurrent, Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Early in 2019, trifluridine/tipiracil tablets were approved for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine; a platinum; either a taxane or...

Gastroesophageal Cancer

Nivolumab vs Taxane Therapy in Refractory Esophageal Squamous Cell Carcinoma

As reported in The Lancet Oncology by Ken Kato, MD, and colleagues, the phase III ATTRACTION-3 trial conducted in predominantly Asian patients has shown a survival benefit with nivolumab vs paclitaxel or docetaxel in patients with advanced esophageal squamous cell carcinoma who were refractory to...

Gastroesophageal Cancer
Gastrointestinal Cancer

Trifluridine/Tipiracil Survival Benefit for Patients With Metastatic Gastric Cancer Who Had or Had Not Undergone Prior Gastrectomy

In a subgroup analysis of the phase III TAGS trial (TAS-102 Gastric Study) reported in JAMA Oncology, David H. Ilson, MD, PhD, and colleagues found positive trends in survival benefit with trifluridine/tipiracil treatment vs placebo for patients with pretreated metastatic gastric cancer or...

Gastroesophageal Cancer
Immunotherapy

Nivolumab vs Chemotherapy in Previously Treated Advanced Esophageal Squamous Cell Carcinoma

As reported in The Lancet Oncology by Kato et al, the phase III ATTRACTION-3 trial conducted in predominantly Asian patients has shown a survival benefit with nivolumab vs paclitaxel or docetaxel in patients with advanced esophageal squamous cell carcinoma who were refractory to or intolerant of...

gastroesophageal cancer

Steven H. Lin, MD, PhD, on Esophageal Cancer: Proton Beam vs Intensity-Modulated Radiation Therapy

Steven H. Lin, MD, PhD, of The University of Texas MD Anderson Cancer Center, discusses phase II findings that showed proton beam therapy improved total toxicity burden score with no difference in progression-free survival when compared with intensity-modulated radiation treatment (Abstract LBA2).

Immunotherapy
Gastroesophageal Cancer

Pembrolizumab in Advanced Esophageal Squamous Cell Cancer With PD-L1 Expression of CPS ≥ 10

On July 30, 2019, pembrolizumab was approved for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express programmed cell death ligand 1 (PD-L1; Combined Positive Score [CPS] ≥ 10), as determined by a U.S. Food and Drug...

gastroesophageal cancer

Can Lymph Node Response to Neoadjuvant Chemotherapy Predict Prognosis in Esophageal Cancer?

In a study published by Urakawa et al in Annals of Surgery, researchers found that the response of lymph nodes to neoadjuvant chemotherapy is more effective in predicting disease recurrence and patient survival in individuals with esophageal cancer than the response of primary tumors....

gastroesophageal cancer
immunotherapy

FDA Approves Pembrolizumab for Some Patients With PD-L1–Positive Esophageal Cancer

On July 30, the U.S. Food and Drug Administration (FDA) approved the programmed cell death protein 1 inhibitor pembrolizumab (Keytruda) as monotherapy for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express programmed ...

lung cancer
gastroesophageal cancer
bladder cancer
gastrointestinal cancer
immunotherapy

Ramucirumab Plus Pembrolizumab in Previously Treated Advanced Gastroesophageal Cancer, NSCLC, and Urothelial Carcinoma

Results from a phase IB trial expansion stage reported in The Lancet Oncology by Herbst et al showed the combination of ramucirumab plus pembrolizumab had manageable toxicity and antitumor activity in previously treated advanced gastroesophageal cancer, non–small cell lung cancer (NSCLC), and ...

Breast Cancer
Gastroesophageal Cancer
Gastrointestinal Cancer

FDA Approves New Trastuzumab Biosimilar

On June 14, the U.S. Food and Drug Administration (FDA) approved trastuzumab-anns (Kanjinti) for all approved indications of the reference product trastuzumab (Herceptin): for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction...

Gastroesophageal Cancer
Gastrointestinal Cancer

Trifluridine/Tipiracil in Recurrent, Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma

In the Clinic provides overviews of novel hematology and oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On February 22, trifluridine/tipiracil...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

Expert Point of View: Ian Chau, MD

IAN CHAU, MD, a consultant medical oncologist at the Gastrointestinal and Lymphoma Units of The Royal Marsden NHS Foundation Trust in London and Surrey, United Kingdom, was the invited discussant of KEYNOTE-062. In an interview with The ASCO Post, he first commented that although single-agent...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

KEYNOTE-062: Pembrolizumab Is a New First-Line Option in Gastric/Gastroesophageal Junction Cancer

KEYNOTE-062, a study of first-line treatment in patients with advanced gastric or gastroesophageal junction adenocarcinoma, found pembrolizumab to be noninferior to chemotherapy and perhaps better than chemotherapy in a subgroup of patients. The results were reported at the 2019 ASCO Annual Meeting ...

breast cancer
gastroesophageal cancer
gastrointestinal cancer

FDA Approves New Trastuzumab Biosimilar

Today, the U.S. Food and Drug Administration (FDA) approved trastuzumab-anns (Kanjinti) for all approved indications of the reference product trastuzumab (Herceptin): for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal...

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 chemotherapy, with fewer side effects (Abstract LBA4007).

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...

breast cancer
gastroesophageal cancer
gastrointestinal cancer

Trastuzumab Deruxtecan in Advanced HER2-Positive Gastric and Breast Cancers

Two phase I studies reported in The Lancet Oncology indicate activity of the antibody-drug conjugate trastuzumab deruxtecan in advanced HER2-positive gastric cancer and advanced HER2-positive breast cancer previously treated with trastuzumab emtansine (T-DM1). Trastuzumab deruxtecan (DS-8201a) is a ...

gastroesophageal cancer

2019 ASCO: Reduced Chemotherapy Dosages in Elderly Patients With Advanced Gastroesophageal Cancer

A phase III randomized clinical study evaluating the optimum dose of a combination chemotherapy regimen of oxaliplatin and capecitabine in the treatment of advanced gastroesophageal cancer in frail and elderly patients has found that the patients prescribed the lowest dose tested experienced less...

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