Member Info for GoSushi

Lartruvo posted slightly more than $300 million in sales In 2018

William Tap is an oncologist who was involved in the clinical trials and research related to olaratumab. He played a significant role in studying the effectiveness of olaratumab in the treatment of soft tissue sarcoma. His work contributed to the initial FDA approval of olaratumab for advanced soft tissue sarcoma in 2016, although, as mentioned earlier, the approval was later revoked in 2019 due to the failure of a confirmatory clinical trial.

Olaratumab, marketed under the brand name Lartruvo, received accelerated approval from the U.S. Food and Drug Administration (FDA) in October 2016 for the treatment of advanced soft tissue sarcoma in adults. However, in April 2019, the FDA revoked the approval due to the failure of a confirmatory clinical trial to demonstrate a clinical benefit. As a result, olaratumab is no longer available for use in the United States.

Market Scenario

The Global Soft Tissue Sarcoma (STS) Market has been estimated to grow with a CAGR of 7.4% During the Forecast year and was holding a revenue of US$ 3,595.41 Mn in 2022 and is projected to reach US$ 6,465.70 Mn by 2030.

Soft-tissue sarcomas are a rare and diverse category of tumors that develop in the connective tissues of animal cells. The tumors are commonly found in connective tissues such as nerves, tendons, muscles, blood vessels, and fibrous tissues, with a higher prevalence in the hands and legs.

My impression is FDA

Like large populations for data

PFS is fantastic but I don’t think the small trial numbers will be enough. Would be fantastic to get expedited approval.

Fingers crossed.

While optimistic, it is possible that FDA approval could come after the P1b study (i.e., before P2 begins). To be clear, P2 will still be required, but ava6k could be on the market while P2 is being carried out.

Hi JT

You posted the above

I have never read of a drug being brought to market after phase one. What makes you think that there could be a slim possibility of this happening? Are there previous cases of this occurring?

So given this information

When do you think the 2week study will be completed?

Thanks for sharing

That is good news particularly the bit about helping keep the timescale short.

One hundred patients with non-small cell lung cancer were entered into a randomized evaluation of two schedules of doxorubicin combined with ftorafur, cyclophosphamide, and cisplatin (FACP). Doxorubicin was given either weekly at 20 mg/m2, or every three weeks (standard) at 60 mg/m2. Fifty-two patients were randomized to the FACP/weekly doxorubicin arm and 48 patients to the FACP/standard doxorubicin arm. The FACP/weekly doxorubicin regimen was associated with higher complete and partial remission rates (31% versus 19%), longer response duration (median, 33 versus 21 weeks), and longer survival duration for responders (median, 58 versus 50 weeks)

Anyone able to provide a rough idea as to when two weekly dosing it completed and data provided for that?

Don’t worry Jive Turkey

The colour of the car will be revealed at the AACR.

Seems a plausible scenario

My Bad… I have found this statement now

Sorry

There was no RNS on 28th Feb 2024 with this info.

There was no RNS on 28th Feb 2024 with this info.

Where is this info from?

Well there is that but also patients can just live longer. Any tumours that responds to regular Dox will respond to AVA6000. So even if efficacy is not better, they will will have little side effects and can be treated for longer. I see that as the current worst case scenario.

I suspect 18th is just a formality regarding share issue and nothing else. Why can’t this company be a bit more forthcoming

Do you think the company will provide an update to shareholders. If so, when do you think this would happen?

Can you give a bit more detail on your theory please?

It’s a crap podcast

They don’t really discuss Avacta at all.

It all seems very odd, given that we were told that “lots want this”. Doesn’t fit with the narrative at all.