Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Spectrum needs to explain why no interim data on Zenith20 cohort 1. They really need to explain that. After giving it further thought, I was too kind in my last post giving a long DoR as a reason why they aren’t releasing topline results since, heck, they have mature ORR data for a while now. The last patient in cohort 1 was dosed around the 2nd week of January so it’s been 8 months since the last patient was dosed. They can determine if there’s a response or stable disease after the 2 month scan and by now they’ll have additional scans at 4, 6, and 8m for the last patient and many more scans for patients who were dosed earlier; that’s, at least, an additional 3 scans that can be used to determine RRs. If there’s a partial response after 2m they can go to the next scan at 4m to see if it progressed or still responding. Ditto if they found stable disease at 2m, they’ll go to the next scan to see if stable, or a partial or complete response, or the patient progressed. They can rinse and repeat every 2m. So they pretty much have topline ORR info in hand. It’s the DoR and PFS that may still be maturing. But I’ve seen lots of abstracts and/or PRs where they give topline ORR and state the PFS or DoR is still maturing. Here’s one recent example from TGTX

TG Therapeutics Announces Positive Outcome from UNITY-NHL Phase 2b Pivotal Trial Evaluating Umbralisib in Patients with Relapsed/Refractory Marginal Zone Lymphoma Feb 28, 2019

Study met the primary endpoint of Overall Response Rate (ORR)

Interim data to be presented in an oral presentation at the 2019 American Association of Cancer Research (AACR) annual meeting on April 1, 2019

Umbralisib was previously granted Breakthrough Therapy Designation based on interim data from the marginal zone lymphoma (MZL) cohort of the UNITY-NHL trial

Conference call to be held today, Thursday February 28, 2019 at 8:30 AM ET

NEW YORK, Feb. 28, 2019 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases, today announced that the Marginal Zone Lymphoma (MZL) cohort of the UNITY-NHL Phase 2b pivotal trial evaluating umbralisib (TGR-1202), our novel, once daily, PI3K delta inhibitor, met the primary endpoint of Overall Response Rate (ORR) as determined by Independent Review Committee (IRC) for all treated patients (n=69). The results met the Company’s target guidance of 40-50% ORR.

Interim safety and efficacy data from this study will be presented in an oral presentation at the upcoming American Association of Cancer Research (AACR) annual meeting on April 1, 2019 and full data from this study are expected to be presented at a medical meeting later this year. The company plans to discuss the results with the U.S. Food and Drug Administration (FDA) regarding a potential new drug application (NDA) filing for accelerated approval. Umbralisib was recently granted Breakthrough Therapy Designation (BTD) by the FDAfor the treatment of adult patients with MZL who have received at least one prior anti-CD20 regimen.

Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, “We are extremely pleased to announce that the UNITY-NHL marginal zone lymphoma cohort evaluating umbralisib monotherapy met the primary endpoint of ORR. While this was an early look at the response data, we were excited to have already met the target ORR, which we previously stated was approximately 40%-50%. Importantly, with many patients still on study, we anticipate the ORR will continue to improve with additional follow-up, which will also provide us with critical information on duration of response, progression free survival and long-term safety and tolerability necessary to support an NDA filing.”

So I really don’t get it. Are they doing it deliberately to keep the share price down so that they can acquire options at a lower price? That’s great for management and shareholders who can load up on cheap shares but not to other investors who committed funds expecting results. I hope it’s not the case but what other reasons are there not to provide topline? We know it's not because of bad data because MDACC's P2 trial already already provided solid data. Yes, not divulging topline till their key secondary endpoints may be more conservative but I’m not buying that right now. They need to explain themselves. I hope the analysts ask them why. Godot must be their middle name.