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Will Bristol-Myers Squibb’s I-O (Opdivo+Yervoy) -ongoing CheckMate 743 study meet the unmet need for untreated malignant pleural mesothelioma (MPM)?

OPDIVO + YERVOY- the new standard of care in Malignant pleural mesothelioma (MPM) Checkmate 743

Malignant pleural mesothelioma (MPM) is a relatively rare but aggressive form of cancer arising from the membrane covering the lungs and the inner side of the ribs. This type of cancer is most frequently a result of inhaling asbestos.

  • Diagnosis is often delayed, with the majority of patients having advanced or metastatic disease at presentation.
  • Prognosis is generally poor: in previously untreated patients with advanced or metastatic malignant pleural mesothelioma,
  • Median survival is less than one year, and the five-year survival rate is approximately 10%.

In May 2019, Food and Drug Administration (FDA) approved Novocure’s NovoTTF-100L System in combination with pemetrexed and platinum-based chemotherapy as a front-line treatment for patients with untreated, unresectable, locally advanced or metastatic malignant pleural mesothelioma (MPM).

Top Line Results Opdivo (nivolumab) + Yervoy (ipilimumab)-CheckMate 743

Recently, BMS reported Positive Topline Result from Pivotal Phase 3 Trial Evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) vs. Chemotherapy in Previously Untreated Malignant Pleural Mesothelioma. 

Mellalta Meets Key Findings-

BMS Checkmate 743 •	Opdivo (nivolumab) in combination with Yervoy (ipilimumab)

CheckMate743

ChechMate743 is a Phase III, Randomized, Open Label Trial of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) Versus Pemetrexed With Cisplatin as First Line Therapy in Unresectable Malignanta Pleural Mesothelioma. The study has shown great efficacy and has met its primary endpoint of overall survival (OS).  Based on a pre-specified interim analysis conducted by the independent Data Monitoring Committee, Opdivo in combination with Yervoy resulted in a statistically significant and clinically meaningful improvement in OS compared to chemotherapy (pemetrexed and cisplatin or carboplatin).

As per the [NCT02899299] results posted on the clinicaltrial site, the study shows that-

  • Primary Outcome Measures:
    • Overall Survival (OS) [ Time Frame: 4.5 years]
      Final OS analysis
  • Secondary Outcome Measures:
    • Objective Response Rate (ORR) [ Time Frame: 4.5 years]
    • Disease Control Rate (DCR) [ Time Frame: 4.5 years]
    • Composite correlation of PD-L1 expression level and efficacy [ Time Frame: 4.5 years] Efficacy determined by the ORR, PFS, and OS
    • Progression Free Survival (PFS) [ Time Frame: 4.5 years]

Result Outcomes

The phase III study performed by Dr. Baas and the global study investigators in randomly assigned more than 600 patients: 303 to the nivolumab + ipilimumab arm and 302 to the chemotherapy arm.

  • The study had a minimal follow up of close to two years-

    • Two-year overall survival rates were 40.8% for the patients in the experimental treatment arm vs 27.0% in chemotherapy arm.
    • Of the 30.3% of patients in the study-combination group who experienced grade 3-4 adverse events, 15% discontinued therapy compared with 7.4% of the 32.0% of patients in chemotherapy group

Sabine Maier, M.D., development lead, thoracic cancers, Bristol Myers Squibb, said

“These topline results from the CheckMate -743 trial demonstrate the potential of Opdivo plus Yervoy in previously untreated patients with malignant pleural mesothelioma, and is another example of the established efficacy and safety of the dual immunotherapy combination seen in multiple tumor types. We look forward to working with investigators to present the results at a future medical meeting, and to discussing them with health authorities.”

Late stage competition in Malignant pleural mesothelioma (MPM)

NCT Number

Study Name

Status

Therapies

Company

Phases

NCT03710876

INFINITE

Recruiting

rAd-IFN|Celecoxib Oral Product|Gemcitabine

Trizell Ltd

Phase 3

NCT03762018

BEAT-meso

Recruiting

Carboplatin|Pemetrexed|Bevacizumab|Atezolizumab

Hoffmann-La Roche

Phase 3

NCT02991482

PROMISE-meso

Active, not recruiting

Pembrolizumab|Gemcitabine|Vinorelbine

Merck Sharp & Dohme Corp.

Phase 3

NCT02899299

CheckMate743

Active, not recruiting

Nivolumab|Ipilimumab|Pemetrexed|Cisplatin|Carboplatin

Bristol-Myers Squibb|Ono Pharmaceutical Co. Ltd

Phase 3

NCT04334759

DREAM3R

Not yet recruiting

Durvalumab|Standard Chemotherapy

PrECOG, LLC.|AstraZeneca

Phase 3

NCT02784171

 

Recruiting

Cisplatin|Pemetrexed|Pembrolizumab

Merck Sharp & Dohme Corp.

Phase 2|Phase 3

NCT02709512

ATOMIC

Recruiting

ADI-PEG 20 plus Pem Cis|Other: Placebo plus Pem Cis

Polaris Group

Phase 2|Phase 3

Bristol Myers Squibb is currently Leader with Strong Set of In-line brands with Opdivo (nivolumab) in combination with Yervoy (ipilimumab) already alone yielding sales >$1 billion. 

Approved Indications with Opdivo+Yervoy combo

  1. Unresectable or metastatic melanoma
  2. Intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC)
  3. Adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
  4. Hepatocellular carcinoma (HCC) who have been previously treated with sorafenib

What we, Mellalta Meets can conclude from the above insights collected is that study has shown tremendous efficacy and all in all Bristol-Myers Squibb CheckMate743 has the potential to be the new standard of care for malignant pleural mesothelioma.

Submit your Request for Proposals at bd@mellalta.com

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