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hepatobiliary cancer
immunotherapy

First-Line Lenvatinib Plus Pembrolizumab in Patients With Unresectable Hepatocellular Carcinoma

In a phase Ib trial reported in the Journal of Clinical Oncology, Richard S. Finn, MD, and colleagues found that the combination of lenvatinib and pembrolizumab produced durable responses in patients with unresectable hepatocellular carcinoma who had received no prior systemic chemotherapy. As...

colorectal cancer

Second-Look Surgery Plus HIPEC vs Surveillance for Patients at High Risk for Colorectal Peritoneal Metastases

In a French phase III trial (PROPHYLOCHIP–PRODIGE 15) reported in The Lancet Oncology, Goéré et al found that second-look surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC) did not improve disease-free survival vs standard surveillance in patients at high risk of developing colorectal...

leukemia

Sorafenib Maintenance After Allogeneic HCT in Patients With FLT3-ITD–Positive AML

In the German-Austrian phase II SORMAIN trial reported in the Journal of Clinical Oncology, Burchert et al found that maintenance treatment with sorafenib vs placebo was associated with significantly prolonged relapse-free survival after allogeneic hematopoietic stem cell transplantation (HCT) in...

skin cancer
immunotherapy

Pembrolizumab in Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma

As reported in the Journal of Clinical Oncology by Grob et al, the first interim analysis of the phase II KEYNOTE-629 trial has shown that treatment with pembrolizumab resulted in durable responses in patients with recurrent or metastatic cutaneous squamous cell carcinoma. The study supported the...

solid tumors
immunotherapy

Pembrolizumab for Adult and Pediatric Patients With Tumor Mutational Burden–High Solid Tumors

In the Clinic provides overviews of novel 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 June 16, 2020, pembrolizumab was granted accelerated...

covid-19
solid tumors
hematologic malignancies

In Case You Missed It: Quick Takes on Novel Therapies for Solid and Hematologic Malignancies

Because of the COVID-19 pandemic, oncology providers from around the world had to forgo their annual trip to McCormick Place—but the show did go on. We all realized important research can still be presented, clinicians and fellow researchers will still listen, and ASCO presentations will still...

ASTRO to Host Virtual Annual Meeting, October 25–28, 2020

The American Society for Radiation Oncology (ASTRO) has announced it will hold its 62nd Annual Meeting October 25–28, 2020, via an interactive virtual platform. The meeting, “Global Oncology: Radiation Therapy in a Changing World,” will feature reports from the latest clinical trials; panels on...

pancreatic cancer

First-Line FOLFIRINOX vs Gemcitabine/Nab-paclitaxel for Localized Pancreatic Cancer

In a single-institution retrospective study reported in JAMA Surgery, Perri et al found that first-line FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin) was associated with a higher response rate and subsequent pancreatectomy vs gemcitabine plus nab-paclitaxel in patients with...

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...

lymphoma
multiple myeloma
immunotherapy

FDA Pipeline: Novel Treatments for Hematologic Malignancies

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to pembrolizumab for the second-line treatment of patients with relapsed or refractory Hodgkin lymphoma, and also accepted a supplemental new drug application for selinexor for pretreated patients with multiple myeloma....

lung cancer

Nivolumab Plus Ipilimumab in Two New Lung Cancer Indications

The combination of nivolumab and ipilimumab was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with non–small cell lung cancer (NSCLC) in two different regimens: On May 15, 2020, the two-drug combination was approved for first-line treatment in...

skin cancer
immunotherapy

Longer-Term Results of Pivotal Study in Advanced Cutaneous Squamous Cell Carcinoma

New, longer-term data from a pivotal phase II trial in advanced cutaneous squamous cell carcinoma (CSCC), were presented during the ASCO20 Virtual Scientific Program and discussed during a poster discussion.1 Danny Rischin, MD, of the Peter MacCallum Cancer Centre, Victoria, Australia, presented...

lymphoma
immunotherapy

Pembrolizumab Improves Progression-Free Survival vs Brentuximab Vedotin in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

Treatment with the anti–PD-1 agent pembrolizumab significantly improved progression-free survival in patients with classical Hodgkin lymphoma compared with standard brentuximab vedotin, according to results of the phase III KEYNOTE-204.1 The study results were presented during the ASCO20 Virtual...

colorectal cancer
immunotherapy

Rates of Progression-Free Survival in MSI-H/dMMR Metastatic Colorectal Cancer Doubled by Pembrolizumab

Upfront treatment with immunotherapy not only improved results in a subset of patients with metastatic colorectal cancer, it doubled the rates of median progression-free survival. These findings—the first of their kind—arose from the interim analysis of the randomized open-label phase III...

gastrointestinal cancer
immunotherapy

Lenvatinib Plus Pembrolizumab for Advanced Gastric Cancer

In the Japanese single-center phase II EPOC1706 trial reported in The Lancet Oncology, Kawazoe et al found high objective response among patients with advanced gastric cancer who received the combination of lenvatinib and pembrolizumab as first- or second-line treatment. Study Details The trial...

gastrointestinal cancer
immunotherapy

Lenvatinib Plus Pembrolizumab for Advanced Gastric Cancer

In the Japanese single-center phase II EPOC1706 trial reported in The Lancet Oncology, Kawazoe et al found high objective response among patients with advanced gastric cancer who received the combination of lenvatinib and pembrolizumab as first- or second-line treatment. Study Details The trial...

kidney cancer

Study Supports Pembrolizumab Plus Axitinib in Previously Untreated Advanced Renal Cell Carcinoma

Extended analysis of the phase III KEYNOTE-426 study upholds pembrolizumab plus axitinib as a preferred front-line regimen over sunitinib in patients with advanced sporadic renal cell carcinoma.1 These updated results were presented at the ASCO20 Virtual Scientific Program by Elizabeth R. Plimack,...

colorectal cancer
immunotherapy

FDA Approves Pembrolizumab for the First-Line Treatment of MSI-H/dMMR Colorectal Cancer

On June 29, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the first-line treatment of patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) colorectal cancer. KEYNOTE-177 Approval was based on...

lung cancer
covid-19

Mortality Risk in Patients With COVID-19 and Thoracic Malignancies: Initial Report From the TERAVOLT Registry Study

As reported in The Lancet Oncology by Marina C. Garassino, MD, and colleagues, initial findings from the Thoracic Cancers International COVID-19 Collaboration (TERAVOLT) registry study have identified potential factors associated with increased risk of mortality in patients infected with COVID-19...

bladder cancer
immunotherapy

Long-Term Outcomes With Pembrolizumab for Cisplatin-Ineligible Advanced Urothelial Cancer

As reported in the Journal of Clinical Oncology by Vuky et al, long-term follow-up in the phase II KEYNOTE-052 study has shown durable responses with first-line pembrolizumab in cisplatin-ineligible locally advanced or metastatic urothelial cancer, with higher response rates and longer survival in...

lung cancer

Capmatinib for Metastatic NSCLC With MET Exon 14 Skipping Mutation

On May 6, 2020, the oral mesenchymal-epithelial transition (MET) kinase inhibitor capmatinib was granted accelerated approval for the treatment of adult patients who have metastatic non–small cell lung cancer (NSCLC) with tumors that have a mutation that leads to MET exon 14 skipping, as detected...

issues in oncology

ASCO20 Virtual Scientific Program: Next-Generation Oncology Highlights

The ASCO20 Virtual Scientific Program was different in many ways, not only because of the virtual modality forced by the COVID-19 pandemic, but also because of the resilience of the scientific society and my colleagues around the world. I’m in the plenary session of the ASCO 2025 Annual Meeting....

prostate cancer

Olaparib for Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer

On May 19, 2020, olaparib was approved for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer who experienced disease progression after treatment with...

lung cancer

First-Line Pembrolizumab Added to Standard Chemotherapy Improved Progression-Free Survival in Extensive-Stage Small Cell Lung Cancer

Pembrolizumab added to etoposide and platinum significantly improved progression-free survival compared with placebo and etoposide/platinum as first-line therapy in patients with newly diagnosed, extensive-stage small cell lung cancer (SCLC).1 These results from the randomized, double-blind, phase...

skin cancer
immunotherapy

FDA Approves Pembrolizumab for Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma

On June 24, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable with surgery or radiation. KEYNOTE-629 Efficacy was investigated in KEYNOTE-629, a multicenter, multicohort,...

solid tumors
immunotherapy

FDA Approves Pembrolizumab for Adults and Children With Tumor Mutational Burden–High Solid Tumors

On June 16, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden–high (TMB-H; ≥ 10 mutations/megabase [mut/Mb]) solid tumors, as determined by an ...

head and neck cancer
immunotherapy

Pembrolizumab Plus Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

In a phase Ib study reported in the Journal of Clinical Oncology, Powell et al found that the addition of pembrolizumab to curative chemoradiotherapy was safe and associated with response in patients with locally advanced head and neck squamous cell carcinoma. Study Details The U.S. multicenter...

gynecologic cancers

Niraparib for First-Line Maintenance Treatment of Advanced Ovarian Cancer

On April 29, 2020, niraparib was approved for maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.1,2 Supporting Efficacy Data Approval was based on...

skin cancer
immunotherapy

KEYNOTE-555 Supports 6-Week Pembrolizumab Dosing Schedule in Melanoma

A less-frequent, more-convenient dosing schedule for pembrolizumab (400 mg every 6 weeks) was deemed safe and effective in patients with unresectable or metastatic melanoma, according to interim data from cohort B enrolled in the KEYNOTE-555 trial. These findings were presented at the 2020 Virtual...

gynecologic cancers

Olaparib Plus Bevacizumab in Maintenance Treatment for Ovarian, Fallopian Tube, or Primary Peritoneal Cancers

On May 8, 2020, olaparib was granted an expanded indication to include use in combination with bevacizumab for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line...

prostate cancer
issues in oncology

Men of Color Remain Underrepresented in Prostate Cancer Clinical Trials

An analysis of 59 prostate cancer clinical trials based in North America and Europe found that the vast majority of enrollees were non-Hispanic white men, according to a study published by Rencsok et al in Cancer Epidemiology, Biomarkers & Prevention. The proportion of white participants in...

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...

prostate cancer

Lutetium-177–Labeled PSMA-617 Improves PSA Response in First Analysis From TheraP Trial in Metastatic Prostate Cancer

Initial results of the randomized phase II TheraP trial show that therapy directed to prostate-specific membrane antigen (PSMA) with lutetium-177–labeled PSMA-617 (LuPSMA) significantly improved prostate-specific antigen (PSA) response compared with cabazitaxel in men with metastatic...

gynecologic cancers

Cediranib/Olaparib vs Standard-of-Care Chemotherapy for Platinum-Sensitive Ovarian Cancer

Results of the NRG Oncology phase III clinical trial NRG-GY004 indicated that the addition of the investigational agent cediranib to olaparib and standard platinum-based chemotherapy did not improve progression-free survival outcomes for women with platinum-sensitive ovarian cancer; however,...

breast cancer

Renowned Researcher and Surgeon Helps to Transform Treatment of Breast Cancer

Although ‘paradigm shifts’ are frequently referenced in oncology, these are really few and far between. They occur when new data either partially invalidate previously accepted theory or are at complete odds with the existing paradigm. Moving away from the Halsted radical mastectomy, a standard of ...

lung cancer
immunotherapy

First-Line Pembrolizumab Plus Etoposide/Platinum for Extensive-Stage Small Cell Lung Cancer

As reported at the ASCO20 Virtual Scientific Program by Charles M. Rudin, MD, PhD, and colleagues (Abstract 9001), the phase III KEYNOTE-604 trial has shown that first-line pembrolizumab plus etoposide/platinum significantly prolonged progression-free survival and prolonged overall survival at a...

colorectal cancer
immunotherapy

Pembrolizumab Doubles Progression-Free Survival in MSI-H/dMMR Metastatic Colorectal Cancer

For the first time, upfront treatment with immunotherapy has improved—in fact, doubled—median progression-free survival in a subset of patients with metastatic colorectal cancer. The findings are from the interim analysis of the randomized open-label phase III KEYNOTE-177 trial comparing the...

integrative oncology

Sleeping Well After Cancer: Patient-Centered Research for Treatment of Insomnia

Insomnia is a persistent sleep disorder that affects nearly 60% of people with cancer, diminishing their quality of life.1,2 Chronic insomnia disorder is defined by trouble falling asleep, staying asleep, or waking too early three times per week for 3 months or more.3 Standard care comprises...

breast cancer

Tucatinib in Previously Treated HER2-Positive Metastatic Breast Cancer

On April 17, 2020, tucatinib was approved for use in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer. These patients included those with brain metastases and those who have received one or more prior...

covid-19

Evolving Insights Into COVID-19 and Cancer Care

Pulling together the 2020 American Association of Cancer Research (AACR) Virtual Annual Meeting in less than 1 month was a Herculean task, and an important component was producing a session on COVID-19 and cancer care. This special session involved researchers from the front lines of the pandemic...

kidney cancer
neuroendocrine tumors
issues in oncology
lung cancer
breast cancer

Selected Poster Presentations on Cancer Therapeutics and More

Although the live 2020 National Comprehensive Cancer Network (NCCN) Annual Conference was canceled, more than 100 posters scheduled for presentation are now available online, as part of the NCCN 2020 Virtual Annual Conference. The ASCO Post has summarized some of the clinical trial updates we found ...

integrative oncology

Yoga for Pediatric and Adolescent Patients With Cancer

The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies sometimes used by patients with cancer. Despite significant improvements reported in survival rates, symptom management in pediatric...

breast cancer
immunotherapy

Neoadjuvant and Adjuvant Pembrolizumab Improves Outcomes in Early Triple-Negative Breast Cancer

As reported in The New England Journal of Medicine by Peter Schmid, MD, PhD, of Barts Cancer Institute, Queen Mary University of London, and colleagues, analyses in the phase III KEYNOTE-522 trial have shown that the addition of pembrolizumab to neoadjuvant chemotherapy and the use of adjuvant...

lung cancer
immunotherapy

Addition of Pembrolizumab to Docetaxel for Previously Treated Immunotherapy-Naive Patients With Advanced Lung Cancer

In the single-institution phase II PROLUNG trial reported in JAMA Oncology, Oscar Arrieta, MD, and Christian Rolfo, MD, PhD, and colleagues found that the addition of pembrolizumab to docetaxel improved objective response rates and progression-free survival in immunotherapy-naive patients with...

gynecologic cancers

FDA Approves Niraparib as Maintenance Therapy for Advanced Ovarian Cancer

On April 29, the U.S. Food and Drug Administration (FDA) approved niraparib (Zejula) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy....

covid-19
lung cancer

AACR 2020: Mortality Rate in Patients With Thoracic Cancers Infected With COVID-19

First results from the TERAVOLT (Thoracic cancERs international coVid 19 cOLlaboraTion) registry for thoracic cancers—presented by Marina C. Garassino, MD, at the American Association for Cancer Research (AACR) Virtual Annual Meeting in the COVID-19 and Cancer Session—indicate a high mortality rate ...

immunotherapy

FDA Approves New Pembrolizumab Dosing Regimen

On April 28, the U.S. Food and Drug Administration (FDA) granted accelerated approval to a new dosing regimen for pembrolizumab (Keytruda)—400 mg every 6 weeks—across all currently approved adult indications, in addition to the current 200 mg every 3 weeks dosing regimen. The approval was based on...

issues in oncology
immunotherapy

Do HIV Positivity and Autoimmune Disease Preclude Treatment With Checkpoint Inhibitors?

Can patients with cancer and preexisting autoimmune disorders safely benefit from immunotherapy? The answer has been unclear, with only retrospective studies and anecdotal reports guiding oncologists. This subpopulation of patients has largely been excluded from clinical trials out of concerns over ...

bladder cancer
immunotherapy

'Switch Maintenance' Pembrolizumab for Metastatic Urothelial Cancer

In a phase II study reported in the Journal of Clinical Oncology, Matthew D. Galsky, MD, and colleagues found that maintenance pembrolizumab produced additional responses and improved progression-free survival vs placebo in patients with metastatic urothelial cancer who had at least stable disease...

lung cancer
immunotherapy

Addition of Pembrolizumab to Docetaxel for Previously Treated Immunotherapy-Naive Patients With Advanced NSCLC

In the single-institution phase II PROLUNG trial reported in JAMA Oncology, Arrieta et al found that the addition of pembrolizumab to docetaxel improved objective response rate and progression-free survival in immunotherapy-naive patients with advanced non–small cell lung cancer (NSCLC) who...

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