Product overview

Oncosil^TM

OncoSil™ comprises of Phosphorous-32 (³²P) Microparticles suspended in a specially formulated Diluent. The Microparticles are a permanent implant which contain Phosphorous-32 (³²P), a pure beta-emitter radioisotope with a physical half-life of 14.27 days. In therapeutic use, 98% of the radiation is delivered within 81 days, which gives an absorbed does equivalent to 100 Gy.³

Intended/Indication for Use

Targeted Approach

The OncoSil™ System is designed and administered to deliver a targeted intratumoural placement of Phosphorous-32 (³²P) while sparing surrounding critical organs⁴

Positive Impact

The prognosis for pancreatic cancer patients has remained almost unchanged for over 40 years⁵. We believe in our technology and our ability to make a positive impact in the lives of patients living with locally advanced pancreatic cancer.

The finding from the PanCO clinical study (ClinicalTrials.gov identifier: NCT03003078) have shown that almost 1 in 4 patients with initially unresectable LAPC who were treated with OncoSil™ in combination with gemcitabine chemotherapy underwent resection surgery. Eight out of 10 of those patients who were resected had R0 surgical margins⁶ .

When compared to CT-only and ICT/CCRT studies, OncoSil™ has been shown to reduce the risk of death and achieve an overall survival of a median 16 months for patients with unresectable LAPC.⁷

Supporting Clinical Data and Publications

Clinical Development – Locally Advanced Pancreatic Cancer

The OSPREY Patient Registry: ClinicalTrials.gov Identifier: NCT04493632

The OSPREY Patient Registry is a multi-centre, post-market, real-world observational registry which has been developed to collect data and assess the performance and safety of the OncoSil™ device when used within the approved indication of unresectable, locally advanced pancreatic cancer, in combination with gemcitabine-based chemotherapy².

The data collected by the OSPREY Registry will provide both complementary and contemporary information to the existing clinical data across various countries and will form part of the post-market clinical follow-up activities for OncoSil™.

Publications

Posters

European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer, virtual, 1–4 July 2020.

Safety and Risk Information

In clinical studies, the following adverse events were considered to have a probable or definite causal relationship with OncoSil™:

• Procedure-related pain
• Abdominal pain and discomfort
• Nausea
• Vomiting
• Lethargy
• Fever
• Abnormal liver function tests

Warnings³

If any signs of damage or ineffective sterile barrier integrity are observed for the OncoSil™ System, DO NOT USE the system and contact OncoSil Medical. Signs of damage and/or ineffective sterile barrier integrity may include, for example, broken vial, cracked vial, broken ring pull, non-intact tamper evident seals, missing vial caps etc.

OncoSil™ System is supplied sterile. There is no data to support the sterility or functionality of OncoSil™ past its expiration date.

Contraindications³

OncoSil™ is contraindicated in patients who have a known history of hypersensitivity to silicon or phosphorous.

OncoSil™ is contraindicated where endoscopic ultrasound (EUS) directed implantation is considered hazardous (refer to Precautions).

Precautions³

Implantation of OncoSil™ should not occur in the following special situations:

• • Presence of multiple collateral vessels surrounding or adjacent to the target tumour
  • Presence (or significant risk) of varices near the target tumour

Caution is advised where previous EUS (eg diagnostic EUS-FNA) was considered technically too difficult.

Caution is strongly advised in the setting of recent, clinically significant pancreatitis. Implantation is not recommended.

Chemotherapy should not be administered within 48 hours either side of the OncoSil™ implantation.

OncoSil™ has not been studied in patients who have previously received radiotherapy to the target organ.

Since the combination of standard radiotherapy and OncoSil™ has not been investigated, additional radiotherapy is not recommended following OncoSil™ treatment.

Antibiotic prophylaxis to cover the OncoSil™ implantation procedure is advised. The selection and duration of antimicrobial regimen is based on local guidelines and practice.

Pain relief may be required to treat abdominal pain experienced immediately following implantation of OncoSil™.

Gastro-protection (e.g. with a proton-pump inhibitor or similar therapy), starting just prior to or at the time of implantation, and continued for up to 6 months post-implantation is considered reasonable.

The safety of OncoSil™ has not been established in patients who are pregnant or who, within twelve months of implantation, become pregnant.

The safety of OncoSil™ has not been established for future children of patients who are pregnant at the time of implantation or who, within twelve months of implantation, become pregnant.

The safety of OncoSil™ has not been established for children being breastfed by patients at the time of implantation or subsequent to implantation.

The safety of OncoSil™ has not been established in patients who are <18 years of age and is therefore not indicated for use in this population group.

Due to limited clinical experience, caution is advised when treating tumours with volumes in excess of 50cc with OncoSil™. A risk-benefit assessment by the implanting physician is strongly advised.

For more information on the handling, preparation, and implantation of OncoSil™, including important safety information, please refer to the OncoSil™ System IFU (Instructions For Use)

Radiation Safety

Radiation safety is an important consideration when using OncoSil™ System. From the receipt of the radioactive material, through preparation of the patient dose, implantation into the patient and release of the patient from the treatment facility there are many radiation safety practices that must be in place. These practices and procedures apply to the staff at the treatment facility, the patient and the patient’s family. The management of risks from ionising radiation requires actions based on the fundamental principles of radiation protection and safety and should be conducted in accordance with best practice in radiological protection.

OncoSil Medical has fully qualified radiation safety personnel on staff and a radiation safety management system in place and utilised on a daily basis. Support from this program is available to the radiation safety personnel, or other personnel as required.

Any loss of containment (spills and/or leakages) of OncoSil™ must be isolated, contained and cleaned up immediately. Area contamination monitoring practices should then be followed to ensure the isolation, containment and cleaning has been effective

Standard procedures and practices used to minimise occupational radiation doses must be affected during storage, handling and use of OncoSil™.

Care must be taken to ensure minimum occupational or other unintended radiation exposure to all staff and other personnel who come into contact with the patient

For more specific guidance on radiation safety as it relates to the OncoSil™ System, refer to the OncoSil™ System Radiation Safety Guidelines.

• For vulnerable groups such as pregnant women, infants and children, the patient should avoid unnecessary contact for 2 weeks.

Staff Precautions

• Individual monitoring of personnel in accredited treatment facilities is a general requirement. There are no special requirements for personnel handling OncoSil™ in relation to dose monitoring. General film badges or some form of personal dosimeter are acceptable.
• Nursing care and ward cleaning requirements will be at the discretion of the treatment facilities radiation safety procedures.

Getting Started

Procedural Overview³

The OncoSil™ System is for use within a licensed treatment facility. The OncoSil™ suspension is prepared by a radiopharmacist or by nuclear medicine personnel (i.e. an Authorised Dispenser). OncoSil™ implantation is performed by an endoscopist and a nuclear medicine physician or radiation oncologist (i.e. an Authorised User).

Both the Authorised User and Authorised Dispenser will have completed a training program provided by OncoSil Medical.

For OncoSil™ implantation, the tumour is accessed by ultrasound guided endoscopy. An overview of the preparation, delivery, and implantation of OncoSil™ is provided below.

Resources

References:
1. In March 2020, the OncoSil™ System received Breakthrough Device designation in the United States for the treatment of patients with locally advanced unresectable adenocarcinoma of the pancreas in combination with systemic chemotherapy by the US Food and Drug Administration (FDA).
2. In April 2020, the OncoSil™ System received CE Marking approval and breakthrough product designation (under MEDDEV 2.7/1 Rev 4) for the treatment of unresectable locally advanced pancreatic cancer in combination with gemcitabine-based chemotherapy from the British Standards Institute (BSI), allowing the OncoSil™ device to be marketed within the European Union and the United Kingdom.
3. OncoSil™ System Instructions for Use.
4. Skowronek J. J Contemp Brachytherapy 2017; 9: 581-589.
5. Cancer Research UK. cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/pancreatic-cancer/survival#heading-Zero (accessed September 2021).
6. Ross PJ, Wasan HS, Croagh D et al. Results of a Single-Arm Pilot Study of 32P Microparticles in Unresectable Locally Advanced Pancreatic Adenocarcinoma with Gemcitabine/Nab-Paclitaxel or FOLFIRINOX Chemotherapy. ESMO Open February 2022; 7 (1): 100356.
7. Allerdice S et al. Presented at the ESMO World Congress on Gastrointestinal Cancer; Ann Oncol 2020; 31 (Suppl 3); Abs. P-260.