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Solid Tumors
Immunotherapy

First-in-Human Study of Anteumab Ravtansine for Advanced Solid Tumors

In a phase I trial reported in the Journal of Clinical Oncology, Hassan et al found evidence of activity of the anti–mesothelin antibody-drug conjugate anetumab ravtansine in patients with advanced solid tumor types known to express the tumor-differentiation antigen mesothelin. The agent consists...

Breast Cancer
Bladder Cancer
Lymphoma
Immunotherapy

FDA Pipeline: Approval of New Dosing for Biosimilar, Plus Two Fast Track Designations

The U.S. Food and Drug Administration (FDA) recently approved a new dose for a biosimilar referencing trastuzumab and granted Fast Track designations to agents for patients with urothelial cancer and follicular lymphoma. Approval of Multidose Vial of Trastuzumab Biosimilar The FDA approved a...

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...

Neuroendocrine Tumors
Immunotherapy

Pembrolizumab in Previously Treated Metastatic High-Grade Neuroendocrine Neoplasms

As reported in the British Journal of Cancer by Namrata Vijayvergia, MD, and colleagues, a pooled analysis of two phase II studies found that pembrolizumab monotherapy showed little activity in patients with previously treated metastatic high-grade neuroendocrine neoplasms. Study Details In the...

Hepatobiliary Cancer
Immunotherapy

Camrelizumab for Previously Treated Advanced Hepatocellular Carcinoma

In a Chinese phase II study reported in The Lancet Oncology, Qin et al found that the programmed cell death protein 1 (PD-1) inhibitor camrelizumab showed activity in patients with previously treated advanced hepatocellular carcinoma. Study Details In the open-label multicenter trial, 217 evaluable ...

Hematologic Malignancies
Immunotherapy

Bispecific Antibodies: Successes and Challenges

Bispecific T-cell engager (BiTE) antibodies, such blinatumomab, may be the most appealing type of bispecific antibodies, a class of manufactured constructs that is expected to expand into the solid tumor space, according to Hermann Einsele, MD, Professor of Medicine at the University of Würzburg,...

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...

Solid Tumors
Immunotherapy

Does Pembrolizumab Show Activity in Some Rare Cancers?

A study published by Naing et al in the Journal for ImmunoTherapy of Cancer found that treatment with pembrolizumab demonstrated acceptable toxicity and antitumor activity in patients with four types of advanced, hard-to-treat rare cancers. “Our findings that pembrolizumab has a favorable toxicity...

Immunotherapy
Lung Cancer

FDA Approves Durvalumab as Part of a First-Line Combination Regimen for Extensive-Stage SCLC

On March 27, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (SCLC). CASPIAN Trial Efficacy of this combination in patients...

Breast Cancer
Immunotherapy

End-of-Study Results From CLEOPATRA: Pertuzumab, Trastuzumab, and Docetaxel in HER2-Positive Metastatic Breast Cancer

As reported in The Lancet Oncology by Sandra M. Swain, MD, and colleagues, long-term follow-up of the phase III CLEOPATRA trial has shown maintained overall survival benefit with the addition of pertuzumab to trastuzumab plus docetaxel in patients with previously untreated HER2-positive metastatic...

Gynecologic Cancers
Immunotherapy

Predicting Which Patients With Ovarian Cancer May Respond to Combination PARP and PD-1 Inhibition

In some patients with advanced ovarian cancer, the combination of programmed cell death protein 1 (PD-1) and poly (ADP-ribose) polymerase (PARP) inhibitors can produce responses, but up until now, investigators have been unable to predict which patients would not benefit from the treatment and...

Kidney Cancer
Immunotherapy

Adding Radiotherapy to Immunotherapy in Renal Cell Carcinoma: Studies Find Mixed Results

Despite recent enthusiasm for combining stereotactic body radiation therapy with immunotherapy in renal cell carcinoma, two preliminary studies presented at the 2020 Genitourinary Cancers Symposium suggest that it may not be the best path forward. In one study, the combination of nivolumab plus...

Head and Neck Cancer
Immunotherapy

Expert Point of View: Tanguy Y. Seiwert, MD

Tanguy Y. Seiwert, MD, moderator of the session on the phase II trial of neoadjuvant nivolumab with or without ipilimumab in patients with oral cavity cancer, underscored concerns about differences in outcome measures. Dr. Seiwert is Director of the Head and Neck Cancer Oncology Disease Group and...

Head and Neck Cancer
Immunotherapy

Phase II Trial Finds Neoadjuvant Immunotherapy Feasible in Oral Cavity Cancer

The results of a phase II study suggest that a short course of immunotherapy prior to surgery for oral cavity cancer may trigger tumor regression, possibly providing long-term benefits for patients. According to data presented at the 2020 Multidisciplinary Head and Neck Cancers Symposium,1 a 3-week ...

Head and Neck Cancer
Immunotherapy

Immune-Restorative Agent May Boost Immunotherapy Response in Advanced Head and Neck Cancer

Immune modulation with checkpoint inhibitors has shown beneficial effects in advanced head and neck squamous cell carcinoma, but responses have been limited to a small number of patients. According to data presented at the 2020 Multidisciplinary Head and Neck Cancers Symposium, however, an...

Bladder Cancer
Immunotherapy

Expert Point of View: Philip J. Saylor, MD

Philip J. Saylor, MD, Attending Physician at Massachusetts General Hospital and Assistant Professor at Harvard Medical School, Boston, commented on this study. “The results that were presented are clearly exciting and cause us to look forward to a likely phase III study of this strategy. The high...

Bladder Cancer
Immunotherapy

Early Data Show Activity for Enfortumab Vedotin Plus Pembrolizumab in Advanced Bladder Cancer

It may be possible to use a platinum-free combination as first-line treatment for advanced or metastatic urothelial carcinoma in cisplatin-ineligible patients, if results of the phase Ib/II EV-103 trial hold up. The combination of the newly approved antibody-drug conjugate (enfortumab vedotin) and...

Gynecologic Cancers
Immunotherapy

Lenvatinib/Pembrolizumab in Previously Treated Patients With Advanced Endometrial Cancer

As reported in the Journal of Clinical Oncology by Vicky Makker, MD, and colleagues, findings from a phase Ib/II trial indicate that the combination of lenvatinib and pembrolizumab is active in patients with previously treated advanced endometrial carcinoma. Study Details The report is the primary ...

Solid Tumors
Lymphoma
Immunotherapy

Nivolumab for Children and Young Adults With Relapsed or Refractory Solid Tumors or Lymphoma

In the phase I/II ADVL1412 study reported in The Lancet Oncology, Davis et al identified the phase II dosage of nivolumab monotherapy in children and young adults with relapsed or refractory solid tumors or lymphoma. Objective responses were observed in patients with lymphoma, but not in those with ...

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...

Colorectal Cancer
Immunotherapy

Expert Point of View: Christopher M. Booth, MD

Christopher M. Booth, MD, the invited discussant of the BEACON CRC quality-of-life findings, applauded the investigators for choosing overall survival and quality of life as endpoints in a trial that benefits a “vulnerable patient population with unmet needs.” Patients with BRAF-mutated metastatic...

Colorectal Cancer
Immunotherapy

Mature Follow-up of BEACON CRC Study Reports Quality-of-Life Measures and Survival Outcomes

For patients with previously treated metastatic colorectal cancer harboring BRAF V600E mutations, the phase III BEACON CRC study showed the benefit for combining two or three targeted agents vs the standard of care.1 With further follow-up, the study has now also shown a benefit for the triplet and ...

Colorectal Cancer
Immunotherapy

TAPUR Basket Study: Biomarker-Driven Treatment Strategies Yield Benefits in Colorectal Cancer

Positive findings on the potential benefit of molecularly targeted drugs in patients with advanced colorectal cancer were presented at the 2020 Gastrointestinal Cancers Symposium, validating the purpose of ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) study.1-3 TAPUR, the first...

Hepatobiliary Cancer
Immunotherapy

Expert Point of View: A. Craig Lockhart, MD

A. Craig Lockhart, MD, Professor of Medicine, University of Miami Sylvester Comprehensive Cancer Center, applauded the study for making patient-reported outcomes a prespecified endpoint and described the value of having this information. Dr. Lockhart was the invited discussant. “The U.S. Food and...

Hepatobiliary Cancer
Immunotherapy

IMbrave150 Prespecified Analysis Adds Improved Quality-of-Life to Survival Benefits Reaped With Atezolizumab Plus Bevacizumab

New findings from a prespecified analysis of the pivotal IMbrave150 trial revealed improved quality of life for patients with advanced hepatocellular carcinoma treated with atezolizumab plus bevacizumab in the first-line setting. These results were reported by Peter R. Galle, MD, at the 2020...

multiple myeloma
lymphoma
immunotherapy

A Discussion About CAR T-Cell Therapy for Multiple Myeloma and Lymphoma

Dr. Armitage discusses the role of CAR T-cell therapy in the management of multiple myeloma and lymphoma in a conversation with his colleagues Dr. Holstein and Dr. Lunning.

Lung Cancer
Immunotherapy

Updated Analysis From KEYNOTE-189: Adding Pembrolizumab to Pemetrexed/Platinum for Nonsquamous NSCLC

An updated analysis from the phase III KEYNOTE-189 trial, reported by Shirish Gadgeel, MB, BS, and colleagues in the Journal of Clinical Oncology, indicated that the addition of pembrolizumab to pemetrexed/platinum chemotherapy continues to be associated with progression-free and overall survival...

Colorectal Cancer
Immunotherapy

Reintroduction of FOLFOXIRI Plus Bevacizumab in Patients With Metastatic Colorectal Cancer

In the Italian phase III TRIBE2 trial reported in The Lancet Oncology, Cremolini et al found that reintroduction of FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) plus bevacizumab after progression on upfront treatment with the regimen was associated with improved...

Colorectal Cancer
Hepatobiliary Cancer
Immunotherapy

Selected Abstracts on Novel Treatments in Colon, Hepatocellular, and Biliary Tract Cancers

The ASCO Post has reported on the pivotal trials presented at the 2020 Gastrointestinal Cancers Symposium in several issues. Featured here are the findings of several additional abstracts worthy of mention. Intermittent Oxaliplatin in Stage II or III Colon Cancer As adjuvant treatment for stage II...

Head and Neck Cancer
Immunotherapy

Expert Point of View: Sue Sun Yom, MD, PhD

Sue Sun Yom, MD, PhD, Professor of Radiation Oncology & Otolaryngology–Head and Neck Surgery at the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, said there is “reasonableness to further investigation” of the combination of programmed cell death...

Head and Neck Cancer
Immunotherapy

Pembrolizumab Plus Radiotherapy Worthy of Further Study in Locally Advanced Squamous Cell Head and Neck Cancer

The combination of the checkpoint inhibitor pembrolizumab and definitive radiation therapy appears to be a safe and feasible option for patients with locally advanced head and neck cancer who are not eligible for cisplatin, according to data presented at the 2020 Multidisciplinary Head and Neck...

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...

Hepatobiliary Cancer
Immunotherapy

FDA Approves Nivolumab/Ipilimumab for Pretreated Patients With Hepatocellular Carcinoma

On March 10, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for patients with hepatocellular carcinoma who have been previously treated with sorafenib. CheckMate 040 Efficacy of the combination was...

Kidney Cancer
Immunotherapy

Expert Point of View: Navid Hafez, MD, MPH

Ilixadencel is essentially a dendritic cell vaccine without preloaded antigens. In the MERECA study, ilixadencel produced “a great signal,” though this approach is still very experimental, said the study’s invited discussant, Navid Hafez, MD, MPH, of Yale Cancer Center. Dr. Hafez is a member of the ...

Kidney Cancer
Immunotherapy

Off-the-Shelf Dendritic Vaccine Shows Benefit in Kidney Cancer

Ilixadencel is a cell-based, allogeneic, off-the-shelf product aimed at priming the anticancer immune response when injected intratumorally. The phase II MERECA study evaluated this allogeneic dendritic cell product given with sunitinib in 88 patients with metastatic renal cell carcinoma. The study ...

Leukemia
Immunotherapy

First-Line Cladribine With Concurrent or Delayed Rituximab for Hairy Cell Leukemia

In a phase II study reported in the Journal of Clinical Oncology, Robert J. Kreitman, MD, and colleagues found that achievement of minimal residual disease–free complete remission for patients with hairy cell leukemia was enhanced by adding concurrent rituximab to first-line cladribine; a lesser...

Leukemia
Immunotherapy

Selected ASH Abstracts on Novel Treatments in Acute Lymphoblastic Leukemia

To complement The ASCO Post’s continued comprehensive coverage of the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on novel therapies for newly diagnosed and relapsed or refractory acute...

Leukemia
Immunotherapy

Expert Point of View: Javier Pinilla-Ibarz, MD, PhD

Javier Pinilla-Ibarz, MD, PhD, of Moffitt Cancer Center, Tampa, Florida, commented on this study: “ELEVATE TN compared front-line treatment with acalabrutinib alone or in combination with obinutuzumab vs obinutuzumab/chlorambucil and showed that a second-generation Bruton’s tyrosine kinase (BTK)...

Leukemia
Immunotherapy

Acalabrutinib Plus Obinutuzumab Superior to Obinutuzumab Plus Chlorambucil as Front-Line Treatment of CLL

Ibrutinib was the first Bruton’s tyrosine kinase (BTK) inhibitor to dramatically transform the treatment of patients with chronic lymphocytic leukemia (CLL) and other hematologic malignancies. The second-generation BTK inhibitor acalabrutinib is a more selective BTK inhibitor designed to have an...

Prostate Cancer
Immunotherapy

Expert Point of View: Charles G. Drake, MD, PhD

In an interview with The ASCO Post, Charles G. Drake, MD, PhD, expounded on the results of the COSMIC-021 trial. Dr. Drake is Division Director for GU Oncology, Co-Director of the Cancer Immunotherapy Program, and Co-Leader of the Tumor Biology and Microenvironment Program at the Herbert Irving...

Prostate Cancer
Immunotherapy

Novel Combination of Cabozantinib Plus Atezolizumab Shows Benefit in Patients With Advanced Prostate Cancer

The combination of the small-molecule tyrosine kinase inhibitor cabozantinib (inhibits VEGF, AXL, MET, and others), plus the immune checkpoint inhibitor atezolizumab achieved encouraging activity in patients with metastatic castration-resistant prostate cancer, according to the results of...

Colorectal Cancer
Immunotherapy

Expert Point of View: Richard L. Schilsky, MD, FACP, FSCT, FASCO

Richard L. Schilsky, MD, FACP, FSCT, FASCO, ASCO’s Chief Medical Officer and a gastrointestinal oncologist himself, was pleased to see the TAPUR study bearing fruit among patients with metastatic colorectal cancer. “Colorectal cancer is a very common disease, but we have not made much progress in...

Colorectal Cancer
Immunotherapy

ASCO’s TAPUR Study: Biomarker-Driven Treatment Paying Off in Colorectal Cancer

New data presented at the 2020 Gastrointestinal Cancers Symposium are validating the purpose of ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) study, a multibasket trial that matches patients’ genomic alterations to commercially available targeted therapies. The aim is to learn...

Immunotherapy
Symptom Management

Expert Point of View: Jarushka Naidoo, MBBCh

“The investigators of the current study tested the hypothesis that vitamin D supplementation is associated with a reduced risk of checkpoint-induced colitis by rigorously assessing 37 variables in both discovery and validation cohorts,” said invited discussant Jarushka Naidoo, MBBCh, Assistant...

Immunotherapy
Symptom Management

Vitamin D Supplementation May Protect Against Checkpoint Inhibitor–Induced Colitis

Vitamin D supplementation prior to starting immune checkpoint inhibitor therapy may significantly reduce the odds of developing colitis, according to a study conducted at Harvard Medical School. Although this was a retrospective chart review, the association was relatively strong in the...

Immunotherapy
Breast Cancer

Small Study Explores Impact of Novel Regimen on Pembrolizumab for Triple-Negative Breast Cancer

In the phase II KEYNOTE-890 trial, patients with inoperable advanced triple-negative breast cancer who received one intratumoral tavokinogene telseplasmid injection followed by electroporation and pembrolizumab, several patients with skin or subcutaneous tumors saw metastatic lesions disappear,...

Breast Cancer
Immunotherapy

Phase III SOPHIA Trial Evaluates Margetuximab/Chemotherapy vs Trastuzumab/Chemotherapy for HER2-Positive Breast Cancer

The second interim analysis of the phase III SOPHIA trial demonstrated a significant though modest improvement in progression-free survival, response rate, and clinical benefit with the addition of margetuximab to chemotherapy vs trastuzumab plus chemotherapy in patients with HER2-positive...

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