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...
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,...
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 ...
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...
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...
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...
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...
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...
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...
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...
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,...
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 ...
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...
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...
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...
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...
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...
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 ...
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...
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...
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...
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....
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 ...
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...
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 ...
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...
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...
Over the past week, the U.S. Food and Drug Administration (FDA) granted Priority Review to an immunotherapeutic agent for solid tumors with a high tumor mutational burden and to a combination treatment for the first-line treatment of metastatic or recurrent non–small cell lung cancer. The agency...
ASCO, in collaboration with international oncology societies, hosts International Palliative Care Workshops (IPCWs) designed to teach participants practical skills in patient communication and the management of cancer symptoms and pain. The IPCWs are led by ASCO member volunteers and local experts...
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...
Improving care for children with cancer worldwide could bring a triple return on investment and prevent millions of deaths, according to a new Commission report published by Atun et al in The Lancet Oncology. Without additional investment in childhood cancer care, new estimates produced for the...
For patients with cancer, the oral blood thinner apixaban is at least as effective as dalteparin, a low–molecular-weight heparin given by injection, in preventing a repeat venous thromboembolism (VTE), with no excess in major bleeding events. These findings from the phase III Caravaggio study were...
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...
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...
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 ...
The staff of The ASCO Post recognizes the steady flow of news on the novel coronavirus, or COVID-19. Here, we've compiled a list of links to articles and resources on the COVID-19 pandemic. If you have a report you'd like to share, please e-mail it to us at editor@ascopost.com. Direct From ASCO:...
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...
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...
On January 23, 2020, tazemetostat was granted accelerated approval for the treatment of adults and pediatric patients aged 16 and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.1,2 Supporting Efficacy Data Approval was based on the finding of...
On January 9, 2020, avapritinib was approved for treatment of adults with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including D842V mutations.1,2 It is the first therapy approved for...
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,...
In patients with triple-negative breast cancer, the addition of pembrolizumab to neoadjuvant and adjuvant chemotherapy achieves higher rates of pathologic complete response compared with placebo, according to results of the phase III KEYNOTE-522 trial presented at the 2019 San Antonio Breast Cancer ...
In a phase Ib/II trial (BTRC-GU14-003) reported in the Journal of Clinical Oncology, Dudek et al found that the combination of pembrolizumab and bevacizumab showed activity in patients with metastatic clear cell renal cell carcinoma. As stated by the investigators, “Anti-angiogenic treatment has...
In a phase I trial reported in JAMA Oncology, Jabbour et al found that the use of pembrolizumab concurrently with chemoradiotherapy in advanced non–small cell lung cancer (NSCLC) was tolerable, and that progression-free survival with the combination therapy was 69.7% at 12 months. As stated by the...
In a single-institution study reported in JCO Oncology Practice, Kiser et al found that implementation of a quality improvement plan significantly reduced the frequency of positron-emission tomography (PET)/computed tomography (CT) radiotracer infiltration among a team of technologists....
As reported in The New England Journal of Medicine by Peter Schmid, MD, PhD, and colleagues, interim analyses of the phase III KEYNOTE-522 trial have shown that the addition of pembrolizumab to neoadjuvant chemotherapy and use of adjuvant pembrolizumab vs placebo resulted in improvements in...
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 allogeneic and autologous hematopoietic cell transplantation. For full...
As reported in The Lancet Oncology by Marina C. Garassino, MD, and colleagues, global health status/quality of life was maintained or improved with the addition of pembrolizumab vs placebo to pemetrexed/platinum therapy for previously untreated metastatic nonsquamous non–small cell lung cancer...
On January 8, 2020, pembrolizumab was approved for treatment of patients with bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.1,2...
Positive findings from three Targeted Agent and Profiling Utilization Registry (TAPUR) study cohorts on the potential benefit of molecularly targeted drugs in patients with advanced colorectal cancer were presented at the 2020 Gastrointestinal Cancers Symposium.1-3 The TAPUR study is the first...