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Cyclacel’s blood cancer drug for elderly patients, sapacitabine fails in phase 3 trial

The blood cancer drug for elderly patients, sapacitabine (CYC682) developed by New Jersey based Cyclacel Pharmaceuticals has failed to meet its objective in a crucial phase 3 study.

An orally-administered nucleoside analogue, sapacitabine did not meet the primary endpoint which was statistically significant improvement in overall survival (OS) in the phase 3 trial named as SEAMLESS.

The blood cancer drug trial was conducted in 70 years or older patients who were newly diagnosed with acute myeloid leukemia (AML) patients who are not fit or have declined to undergo intensive induction chemotherapy.

Commenting on the outcome of the blood cancer drug trial, Spiro Rombotis, President and Chief Executive Officer of Cyclacel said: “We are disappointed not to have reached the primary endpoint of SEAMLESS. Nevertheless, the improvement in CR rate and similar safety profile are encouraging.

“We plan to discuss the data with European and US regulatory authorities once subgroup analyses are completed over the next few months and will report our further plans as they develop. We are grateful to the clinical investigators, and especially the patients and their families, for their contributions to this large study.

“In parallel with data analysis and regulatory discussions, we will reevaluate our continued investment in sapacitabine in hematological malignancies. Our clinical development strategy in oncology will now concentrate on our two ongoing, clinical programs in DNA damage response and transcriptional regulation, which include our area of historical expertise in CDK inhibitors.

“These programs target biomarker-selected patients, such as those with BRCA mutations or resistance to existing cancer therapies. Our cash resources are projected to fund these activities and operations through the end of 2018.”

leukemia generic image

Leukemia. Photo courtesy of David Castillo Dominici/Freedigitalphotos,net.

As far as the mechanism of the Cyclacel’s blood cancer therapy is concerned, sapacitabine, a second generation CDK2/9 inhibitor from the pharma helps in producing DNA double strand breaks (DSBs) and/or checkpoint activation through a novel DNA single-strand breaking mechanism.

However, in comparison to the experimental arm in the phase 3 trial, Cyclacel’s blood cancer drug sapacitabine did not show any considerable difference for not only the primary endpoint but also for the other endpoints.

The blood cancer medication from Cyclacel subjected orally in combination with decitabine given intravenously in alternating cycles was trialed against the treatment of decitabine, administered alone intravenously.

One of the positives from the blood cancer drug trial was that the rate of complete remission (CR) was improved in patients who had discontinued treatment at the time of analysis. This was one of the secondary endpoints of the leukemia clinical trial.

Speaking on the phase 3 results of Cyclacel leukemia drug, Hagop Kantarjian M.D., Professor and Chair, Department of Leukemia, The University of Texas MD Anderson Cancer Center, and chair of the SEAMLESS study said: “The results of the SEAMLESS Phase 3 study demonstrate that sapacitabine is active and safe in elderly AML patients.

“Although the experimental arm of alternating decitabine-sapacitabine did not reach statistically significant superiority in overall survival, it is remarkable that an improvement in complete remission rate was observed.  Additional analysis of stratified and exploratory subgroups is warranted to identify patients who are most likely to benefit from treatment with the experimental arm.”

Cyclacel Pharmaceuticals also revealed that the overall survival improved in a stratified patient subgroup which received the pharma’s blood cancer drug, sapacitabine. This group had patients with low baseline peripheral count for their white blood cells and made up two-thirds of the patient population in the blood cancer therapy trial.

On the contrary, Cyclacel leukemia drug could not demonstrate any improvement in the overall survival of the acute myeloid leukemia patients having high count of white blood cells.

With the leukemia drug not yielding the desired results in the phase 3 trial, Cyclacel Pharmaceuticals intends to relook into its continued investment in further development of sapacitabine as a blood cancer therapy.

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