Trulicity ® (dulaglutide)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information.For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).

Does Trulicity® (dulaglutide) increase the risk of pancreatic cancer?

Results from phase 2 and 3 clinical studies do not suggest an increased incidence of malignancy including pancreatic cancer with dulaglutide.

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Pancreatic cancer reported in clinical studies phase 2 and 3

No patients who received placebo or any active comparator reported pancreatic cancers.1

Two cases of pancreatic carcinoma were reported in patients receiving dulaglutide in the completed phase 2 and phase 3 studies. These 2 patients both

  • had a shorter duration of diabetes that was ≤3 years, and
  • a baseline body mass index (BMI) less than 25 kg/m2.1

The first patient was diagnosed with a large, nonresectable tumor 1 week after their first and only dose of dulaglutide 0.75 mg. It was Lilly’s assessment that this tumor preceded initiation of dulaglutide.1

After approximately 5 months of exposure to dulaglutide, the second patient was found to have a large tumor that consumed most of the body and tail of their pancreas. Given the patient’s short exposure to dulaglutide and the large tumor size, Lilly believes that this tumor was preexisting.1

Results from phase 2 and phase 3 clinical studies do not suggest an increased incidence of malignancy in general or any specific malignancy type with dulaglutide treatment. However, for a rare disease with a long latency period like pancreatic cancer, malignancies in ongoing studies will continue to be carefully assessed in addition to risk assessment through postmarketing cases and exposure.1

Pancreatic cancer in the REWIND Study

The REWIND study was an event-driven, randomized, double-blind, phase 3 study evaluating once-weekly dulaglutide 1.5 mg treatment compared with placebo when added to standard of care on a composite endpoint of MACE-3 (major adverse cardiovascular events: death due to cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes mellitus (T2DM) and established cardiovascular (CV) disease and/or risk factors.2

Dulaglutide 1.5 mg significantly reduced MACE-3 when compared to placebo: (hazard ratio HR=0.88 [95% CI 0.79, 0.99]; p=.026), demonstrating a decrease in CV events and showing safety in a population that included a majority of participants without established CV disease.2

Of the 4949 patients receiving dulaglutide, 19 patients experienced pancreatic cancer. A total of 4952 patients received placebo, 12 of which reported having pancreatic cancer. The frequency of a prespecified adverse events, such as pancreatic cancer, did not differ significantly between the dulaglutide and placebo treated groups.2

Pancreatic cancer reported during postmarketing phase 

Pancreatic carcinoma and metastatic pancreatic carcinoma have been very rarely reported in Lilly postmarketing reports through September 18, 2018 (<0.01%).1

Spontaneous reporting of adverse events (AE) can be highly variable and is not controlled clinical information on which to assess the causality of a drug to an AE.1 

Spontaneous reporting has limitations due to bias in reporting, including incomplete information concerning the patient. These data do not represent the rate of occurrence of an AE; they merely represent the rate of reporting of a particular AE to the company.1

Carcinogenicity in preclinical safety studies

In a 6 month carcinogenicity study in transgenic mice, there was no tumorigenic response.3 

In a 2 year carcinogenicity study in rats, at ≥ 3 times the human clinical exposure following 4.5 mg dulaglutide per week, dulaglutide caused statistically significant, dose-related increases in the incidence of thyroid C-cell tumours (adenomas and carcinomas combined). The clinical relevance of these findings is currently unknown.3

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Gerstein HC, Colhoun HM, Dagenais GR, et al; REWIND Investigators. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019;394(10193):121-130. https://doi.org/10.1016/S0140-6736(19)31149-3

3Trulicity [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Date of Last Review: 03 November 2019


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