FDA Approves Duvelisib for CLL and Follicular Lymphoma - Sep 24, 2018

[lankisterguy]

FDA Approves Duvelisib for CLL and Follicular Lymphoma

Published: Monday, Sep 24, 2018

The FDA has approved duvelisib (Copiktra) for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or relapsed/refractory follicular lymphoma.

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The CLL/SLL indication is a standard approval and the follicular lymphoma indication is an accelerated approval contingent on the results of a confirmatory trial. Both indications are for the treatment of patients who have received at least 2 prior therapies.

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The approval is based on from the phase III DUO trial and the phase II DYNAMO study. In DUO, duvelisib reduced the risk of disease progression or death by 60% versus ofatumumab (Arzerra) in patients with relapsed/refractory CLL/SLL who had received at least 2 prior lines of therapy. The median progression-free survival was 16.4 months with duvelisib versus 9.1 months with ofatumumab (HR, 0.40). In the DYNAMO study, duvelisib demonstrated an overall response rate of 42% in patients with follicular lymphoma.

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“Copiktra is an important addition to the evolving treatment paradigm for patients with CLL/SLL and follicular lymphoma,” Ian Flinn, MD, PhD, director of the Lymphoma Research Program at Sarah Cannon Research Institute and lead investigator of the DYNAMO and DUO studies.

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“The approval of Copiktra for the treatment of relapsed or refractory CLL/SLL after at least two prior therapies, or relapsed or refractory FL after at least two prior systemic therapies, is based on clinical trial data gathered from the treatment of over 400 adult patients. Copiktra is a significant addition to physicians’ treatment armamentarium that I believe will address an unmet need for patients who have limited options once they have progressed after two prior therapies,” add Flinn.

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The phase III DUO study randomized 319 patients with CLL/SLL in a 1:1 ratio to duvelisib at 25 mg twice daily until disease progression or unacceptable toxicity, or ofatumumab at 300 mg on day 1, followed by 7 weekly infusions and 4 monthly infusions of 2000 mg.

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The FDA based its approval on a subset of these patients with CLL/SLL who had received ≥2 prior lines of therapy. The subset included 95 patients randomized to duvelisib and 101 patients who received ofatumumab. This median patient age across this subset was 69 years (range, 40-90), 88% had an ECOG performance status of 0 or 1, and 59% were male. At baseline, 22% of patients had a detected 17p deletion and 52% had 1 or more tumors ≥5 cm. Over half (54%) of this group had received ≥3 prior treatment lines, with the remaining 46% having received 2.

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The median duration of treatment exposure for the duvelisib arm was 13 months (range, 0.2-37). Patients were exposed to ofatumumab for a median duration of 5 months (range, <0.1 to 6). The ORR was 78% with duvelisib versus 39% with ofatumumab.

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Len

P.S. It seems the drug companies love to choose words that are difficult to pronounce Copiktra really???

[Justasheet1]

Dr Flynn explains it

onclive.com/onclive-tv/dr-f...

Len,

So this is after 2 lines of therapy?

I wonder if a combo such as V+R counts as 1or 2?

Sounds like this drug at present is a bridge to transplant unless someone fails a couple of treatments due to adverse events.

Per Dr Wierda,” Moving from chemoimmunotherapy to an ibrutinib-based therapy or to a venetoclax-based therapy, and then moving to a third-line PI3 kinase inhibitor-based therapy, would be the sequence of what we see today. That’s going to change because, as I mentioned, more patients are getting ibrutinib upfront. We might see ibrutinib first followed by venetoclax-based therapy followed by PI3 kinase inhibitors. Chemoimmunotherapy is somewhere, more likely prior to transplant if a patient has progressive disease and they’ve failed several prior lines of therapy.”

I hoped for a broader approval.☹️

Now I’m waiting on Acalabrutinib to be approved. 🙏🏻

Jeff

[Cllcanada Top Poster CURE Hero in reply to Justasheet1]

It will be interesting what this does to Zydelig (idelalisib)/rituxan... same target, fewer side effects... but still some... Zydelig (idelalisib) still has second line slot... but ...

~chris

[Justasheet1 in reply to Cllcanada]

Where is TGR’s pill Umbralisib at? I thought that was the best of the PI3k’s

[Cllcanada Top Poster CURE Hero in reply to Justasheet1]

They haven't started the New Drug Approval..NDA process that I have seen...

tgtherapeutics.com/pipeline...

~chris

[Justasheet1 in reply to Cllcanada]

Oh boy. It could be a while then.

[MelindaBates]

After CAR T didn’t work in Dec., I’m now on Copiktra (Duvelisib). It’s been a month and the bulky tumors are shrinking, slower than Venetoclax, but we’ll see. So far, so good. Only side effects are gastrointestinal, muscle pain, and the ever-persistent fatigue. Persistently vexing CLL. Dx 10/13. I think this is treatment 8. This is getting very old, and if Copiktra stops working, I’m calling it done.