Post by
Noteable on Sep 15, 2024 4:43pm
Pelareorep in 3rd line HR+/HER2 negative breast cancer
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.
Comment by
Noteable on Sep 15, 2024 4:46pm
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
Comment by
Noteable on Sep 16, 2024 9:58pm
Unfortunately most of the stuff that you posted is incorrect, starting with your claim that these 3rd line patients are immune compromised. Simply wrong.
Comment by
inthno on Sep 16, 2024 10:13pm
Well that is most interesting as it has always been stated that we felt that 1st line patients would most likely do better as they had a stronger immune system compared to patients that had gone through previous chemo and were therefore had a more compromised immune system. So note u are saying that 3rd line patients immune systems are as good as 1st line. Hmmm
Comment by
Noteable on Sep 17, 2024 10:28am
Da_man/inthno keep on thinking what you want to think. The Bracelet-1 OS clinical benefit will dictate what comes next. Since your thinking has been quite contentious and set in concrete, nothing much will change your mind now. You Homer, should spend some time and Google to see that nobody has been eating either cats or dogs in Sprinfield. Bye
Comment by
inthno on Sep 17, 2024 10:50am
No problem, I guess what u r telling me is u don't know the answer which is fine. And t least I m realistic and give both sides chance. Go he'd ND keep posting redundant material and.talking about 10 billion dollar buy outs.
Comment by
Buckhenry on Sep 17, 2024 5:55pm
Ole unnoteable just can stand it when someone has a different opinion or thought. He strongly believes in DEI as long as you agree with everything he says. He has become the term that just won't flush.
Comment by
Noteable on Sep 17, 2024 5:04pm
https://stockhouse.com/companies/bullboard?symbol=oncy&postid=36227894
Comment by
Noteable on Sep 25, 2024 5:49pm
The patent expiry date for Daichii-Sanyo / AstraZeneca's antibody-drug conjugate (ADC) Enhertu (T-DM1) in Europe was June 2020. The patent is set to expire in September 2026
Comment by
Noteable on Sep 25, 2024 10:25pm
Correction: Enhertu (trastuzumab deruxtecan) is T-DMx while Kadcyla (trastuzumab emtansine) is T-DM1.
Comment by
Noteable on Sep 25, 2024 10:31pm
The Enhertu patent in the United States expires in November 2024. https://www.fiercepharma.com/pharma/seagen-awarded-418-million-royalties-enhertu-patent-case-against-daiichi-sankyo
Comment by
Noteable on Sep 26, 2024 11:58am
Clarification: Enhertu (trastuzumab deruxtecan) is T-DXd
Comment by
13X2413 on Sep 26, 2024 2:24pm
Clarification: Down again today on a whopping 20,000 shares. No interest in what ONC allegedly has.
Comment by
Buckhenry on Sep 26, 2024 2:30pm
Putting all my hope in the analyst price targets???? Any word on that buyout unnoteable??
Comment by
Noteable on Sep 25, 2024 5:59pm
Correction: Out of the approximate 446,000 women newly diagnosed with HR+/HER2 negative breast cancer globally each year, ONCY has estimated that approximately 55,000 women with HER2- mBC in the United States will progress to 3rd line mBC therapy which ONCY has stated will be eligible for pelareorep (monotherapy) + paclitaxel treatment.
Comment by
Noteable on Oct 01, 2024 1:08pm
RGT-419B, is in Phase 1 testing in hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer patients who progressed on prior CDK4/6 inhibitors. All 12 of the women in the analysis had previously received Pfizer’s CDK4/6 inhibitor Ibrance. Two patients had also taken Novartis’ Kisqali or Eli Lilly’s Verzenio, other approved CDK inhibitors.
Comment by
13X2413 on Oct 01, 2024 2:26pm
Are you giving us this info to help explain the run to a new 3 year low?
Comment by
Buckhenry on Oct 01, 2024 3:19pm
But but but..... the forever pumpers are not concerned with... how low can you go...
Comment by
Buckhenry on Oct 01, 2024 5:15pm
Well we went from dreams of a buyout with a B to an M.. bargain basement sale.
Comment by
Buckhenry on Oct 01, 2024 5:50pm
Fact: living is hazardous to your health!!
Comment by
Noteable on Oct 01, 2024 4:13pm
Should read: Today September 30, 2024 - Roche/Genentech announced an US$850 Million up-front cash payment for the acquisition of this single indication breast cancer product base on only one Phase 1 clinical trial results involving 12 patients.
Comment by
Noteable on Oct 02, 2024 2:06pm
Roche/Genentech announced an US$850 Million up-front cash payment (with future follow-on development milestone payments) for the acquisition of Regor Therapeutics single indication small molecule breast cancer product that is in early stage development had nothing to do with share price since Regor is not listed on any stock exchange, which the naysayers keep deliberately missing.
Comment by
13X2413 on Oct 02, 2024 3:32pm
More evidence....ONC has nothing to offer. Being left in the dust.