RE:Pelareorep in 3rd line HR+/HER2 negative breast cancerSince some have difficulty seeing, I'll repost the following assessment for their benefit...
ONCY should easily be able to enroll 180-200 patients for its Phase2b -> Phase3 -> Confirmatory metastatic breast cancer patients since there is a significant unmet need for patients who will progress from Enhertu 2nd line therapy.
Given the unmet medical need in 3rd line mBC that pelareorep + paclitaxel is seeking to address, ONCY is looking to enroll study patients in the United States and EU - so there should be plenty of available clinical trial participants.
Adding to the straightforwardness of ONCY enrolling patients into their Phase2 -> Confirmatory trial includes factors such as: (1) patients who have progressed from Enhertu will already have been identified as those who are eligible for 3rd line pelareorep + paclitaxel treatment making it a seamless transition from the ADC treatment to pelareorep, and (2) patients will be recruited from the United States and the EU, where patients populations are high and where patient types are diverse and demonstrated to have responded to pelareorep in several clinical trials already performed. Therefore the number of 180-200 should be easy to reach by ONCY or whatever Big Pharma company that acquires ONCY and runs the trial themselves.
ONCY will NOT be dealing with a different patient population than that trialed in the Phase 2 IND-213 and Bracelet-1 clinical trials. ONCY will be dealing with the same patient population who have failed a 2nd line breast cancer therapy, whether it was CDK4,6 inhibitors or ADC Enhertu, whose active payload is a chemotherapy - the same therapies that pelareorep was up against in various other completed ONCY trials in which pelareorep had successfully achieved effective results.
So those patients who have failed Enhertu will have already been identified as eligible pelareorep ready patients. Consequently clinical trial enrollment should be relatively easy by ONCY or the Big Pharma who acquires ONCY and runs the trial towards an accretive Accelerated Approval that would potentially be subsequently followed by a full approval on the same trial data.
In 2022, there were 2.3 million women diagnosed with breast cancer and 670 000 deaths globally.
https://www.who.int/news-room/fact-sheets/detail/breast-cancer
In 2024 approximately 310,720 women and 2,800 men will be diagnosed with invasive breast cancer in the United States.
There are currently more than 4 million women with a history of breast canacer in the United States. This includes women who are being treated and women who have finished treatment.
https://www.breastcancer.org/facts-statistics
In 2022, approximately 604,900 women were diagnosed with breast cancer in the WHO Europe region. Incidence in the EU-27 in 2022 was estimated to be 375,000
https://www.europadonna.org/breast-cancer/
Breast cancer is the most common cancer diagnosed in women in North America. Hormone receptor positive (HR+) and HER2 negative (HER2−) breast cancers account for at least 60% to 70% of all breast cancer.
cases.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8188964/
Consequently, based on 2022 numbers, approximately 685,700 women were diagnosed with invasive breast cancer just in the United States and the EU -27. With HR+/HER2 negative accounting for approximately 65% of all breast cancers - approximately 446,000 women will be diagnosed each year with HR+/HER2 negative breast cancer in the US and EU-27.
Out of the approximate 446,000 women newly diagnosed HR+/HER2 negative breast cancer each year, ONCY has estimated that approximately 55,000 of these women will progress to 3rd line mBC therapy which ONCY has stated will be eligible for pelareorep (monotherapy) + paclitaxel treatment.
ONCY should be able to eadily enroll 180-200 patients for its Phase2b -> Phase3 -> Confirmatory metastatic breast cancer patients since there is a significant unmet need for patients who will progress from Enhertu 2nd line therapy.
Presently overall survival data has from ONCY’s BRACELET-1 metastatic breast cancer Phase 2 study continued to mature, suggesting overall survival (OS) 2+ year data should reflect the statistical significance seen in the 12 month, and showing the clinical benefit that the FDA is needing to grant pelareorep an Accelerated Approval in 3rd line mBC.
12 month data from the BRACELET-1 study has already validated the results of IND-213, a prior phase 2 trial that showed a statistically significant which demonstrated a near doubling of median overall survival in HR+/HER2- metastatic breast cancer patients treated with pelareorep combined with paclitaxel (21.0 months, n = 28) vs. those treated with paclitaxel alone (10.8 months, n = 29).
An ASCO Meeting Abstract from the 2022 ASCO Annual Meeting has cited that the average cost for the first year of HR+/HER2 negative was US$192,367 per patient. With ONCY stating that approximately 55,000 women would become eligible for 3rd line pelareorep + paclitaxel treatment, and a per patient cost of US$192K, this patient group would translate into approximately US$10.56 Billion in annual sales for pelareorep or a significant percentage of this gross sales value, in HR+/Her2 – mBC, that ONCY or a Big Pharma acquirer of ONCY would seek to achieve.
https://ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.e18834
The long view is eventually moving pelareorep into first line therapy in combination with a variation of immune checkpoint inhibitors +/- bispecifics +/- ADCs +/- small molecule inhibitors +/- CAR-T therapy, for example.