Nav: Home

Durvalumab added to standard chemotherapy improved overall survival in mesothelioma

May 20, 2020

PrECOG, LLC is reporting clinical efficacy and biomarker analyses from its single-arm phase two study PrE0505 for the initial treatment of patients with malignant pleural mesothelioma. The trial evaluated adding durvalumab, an immune checkpoint antibody targeting PD-L1, to chemotherapy consisting of pemetrexed and cisplatin (Pem-Cis), the only FDA approved regimen, in 55 patients of any histologic subtype. The study met its primary endpoint with a median overall survival (OS) of 20.4 months (one-sided P=0.0014) as compared to historical control (Vogelzang et al. J Clin Oncol 2003) of 12.1 months. OS rates at 12 and 24 months were 70.4% and 44.2%, respectively. The combination was well-tolerated with no unexpected toxicities.

The American Society of Clinical Oncology (ASCO) is highlighting these data in an oral session (Abstract 9003) at its virtual Annual Meeting, May 29-31.

"Durvalumab plus standard chemotherapy delivered a promising median overall survival rate for patients with previously untreated, inoperable malignant pleural mesothelioma," said lead investigator Patrick Forde, MD, of Johns Hopkins University. "The data signal us to move forward with a phase three study."

PrE0505 study investigators at 15 US clinical sites rapidly enrolled 55 patients into the study over 13 months, between June 2017 and June 2018. Eligible patients received the combination of pemetrexed (500 mg/m2) and cisplatin (75 mg/m2) with durvalumab (1120 mg) every three weeks for up to six cycles. Substitution of carboplatin (AUC 5) for cisplatin was permitted if toxicity occurred during the initial treatment. After up to six cycles of concurrent chemotherapy with durvalumab, patients who had a partial response or stable disease could continue on durvalumab until disease progression. The maximum duration of durvalumab treatment was 12 months from the start of therapy.

"This is a remarkable result in mesothelioma, and warrants confirmation in a randomized phase three trial, which is already in the planning," said Peter J. O'Dwyer, MD, CEO and Chair, PrECOG, LLC.

The secondary endpoints in the PrE0505 trial are safety and tolerability, PFS, and objective response rate. PFS at six months was 69.1%. Best responses to treatment were measured by the RECIST criteria and included 31 patients (56.4%) with partial response, 22 (40%) with stable disease, and one (1.8%) who progressed during the evaluation period. One patient was not evaluable for response. All patients were evaluated for safety, and there were no unexpected toxicities. Adverse events reported by investigators as associated with durvalumab were generally mild in severity (Grade 1 and 2).

In analyses of exploratory objectives, researchers saw no statistically significant associations between tumor sample expression of PD-L1 or tumor mutational burden and progression or survival. They observed neoantigen-specific T-cell responses in some selected cases. Analytical work for the study is ongoing.
-end-
The PrE0505 study was conducted independently by PrECOG, LLC, with funding from AstraZeneca Pharmaceuticals LP.

The clinicaltrials.gov record for PrE0505 is NCT02899195.

About PrECOG

PrECOG, LLC is a cancer research group formed as a not-for-profit limited liability company in 2006 by the ECOG Research and Education Foundation, Inc. It operates outside of the National Cancer Institute's federal funding structure, known as the National Clinical Trials Network. A central focus of PrECOG is to support the overall scientific research goals of the ECOG-ACRIN Cancer Research Group. PrECOG aims to reduce the burden of cancer by advancing research in all aspects of cancer care and thereby improve survival, patient benefit, and quality of life. The current PrECOG portfolio includes phase one and two multi-center trials, as well as US-based and multi-national phase three trials. For further information, please visit http://www.precogllc.org and http://www.ecog-acrin.org, and follow us on Twitter @PrECOGonc and Facebook.

ECOG-ACRIN Cancer Research Group

Related Mesothelioma Articles:

checkmate 743 shows that dual immunotherapy, nivolumab + ipilimumab
The combination of first-line nivolumab and ipilimumab demonstrated an improvement of overall survival for patients with unresectable malignant pleural mesothelioma compared to platinum-based chemotherapy, according to research presented today at the International Association for the Study of Lung Cancer Virtual Presidential Symposium.
Novel treatment for mesothelioma shows promise for patients
novel treatment for advanced mesothelioma is safe and effective and may improve the quality of life for patients who have few treatment options, according to a research abstract presented during a virtual session of the Society of Interventional Radiology's 2020 Annual Scientific Meeting on June 14.
Chemotherapy/immunotherapy combo shows promise for first-line treatment of mesothelioma
Inoperable malignant pleural mesothelioma, is a rare and aggressive cancer of the protective lining of the lungs, or pleura, often caused by exposure to asbestos.
Durvalumab added to standard chemotherapy improved overall survival in mesothelioma
PrECOG, LLC is reporting on its single-arm phase two study PrE0505 for the initial treatment of patients with malignant pleural mesothelioma.
Two drugs used in combination prove to be effective against most aggressive asbestos cancer in mice
Currently, there are few effective treatments for malignant mesothelioma, although it has been decades since it was found that the major risk factor is exposure to asbestos.
Secretome of pleural effusions associated with non-small cell lung cancer (NSCLC) and malignant...
Cryopreserved cell-free PE fluid from 101 NSCLC patients, 8 mesothelioma and 13 with benign PE was assayed for a panel of 40 cytokines/chemokines using the Luminex system.
Secretome of pleural effusions associated with non-small cell lung cancer (NSCLC) and malignant meso
Cryopreserved cell-free PE fluid from 101 NSCLC patients, 8 mesothelioma and 13 with benign PE was assayed for a panel of 40 cytokines/chemokines using the Luminex system.
Mesothelioma trial suggests immunotherapy as an alternative to chemotherapy
Patients with mesothelioma may gain similar benefit from immunotherapy as chemotherapy, and good responders may provide important clues to novel treatment for the thousands of new cases each year.
Radiotherapy doubles survival for patients with mesothelioma
Mesothelioma patients are twice as likely to survive for two years or longer, if they are treated with a high dose of radiation to the affected side of the trunk, according to research presented at the ESTRO 38 conference.
Mesothelin-targeted CAR T-cell therapy shows early promise in patients with solid tumors
A chimeric antigen receptor (CAR) T-cell therapy that targets the protein mesothelin showed no evidence of major toxicity and had antitumor activity in patients with malignant pleural disease from mesothelioma, according to results from a phase I clinical trial presented at the AACR Annual Meeting 2019, March 29-April 3.
More Mesothelioma News and Mesothelioma Current Events

Trending Science News

Current Coronavirus (COVID-19) News

Top Science Podcasts

We have hand picked the top science podcasts of 2020.
Now Playing: TED Radio Hour

Warped Reality
False information on the internet makes it harder and harder to know what's true, and the consequences have been devastating. This hour, TED speakers explore ideas around technology and deception. Guests include law professor Danielle Citron, journalist Andrew Marantz, and computer scientist Joy Buolamwini.
Now Playing: Science for the People

#576 Science Communication in Creative Places
When you think of science communication, you might think of TED talks or museum talks or video talks, or... people giving lectures. It's a lot of people talking. But there's more to sci comm than that. This week host Bethany Brookshire talks to three people who have looked at science communication in places you might not expect it. We'll speak with Mauna Dasari, a graduate student at Notre Dame, about making mammals into a March Madness match. We'll talk with Sarah Garner, director of the Pathologists Assistant Program at Tulane University School of Medicine, who takes pathology instruction out of...
Now Playing: Radiolab

What If?
There's plenty of speculation about what Donald Trump might do in the wake of the election. Would he dispute the results if he loses? Would he simply refuse to leave office, or even try to use the military to maintain control? Last summer, Rosa Brooks got together a team of experts and political operatives from both sides of the aisle to ask a slightly different question. Rather than arguing about whether he'd do those things, they dug into what exactly would happen if he did. Part war game part choose your own adventure, Rosa's Transition Integrity Project doesn't give us any predictions, and it isn't a referendum on Trump. Instead, it's a deeply illuminating stress test on our laws, our institutions, and on the commitment to democracy written into the constitution. This episode was reported by Bethel Habte, with help from Tracie Hunte, and produced by Bethel Habte. Jeremy Bloom provided original music. Support Radiolab by becoming a member today at Radiolab.org/donate.     You can read The Transition Integrity Project's report here.