NorthWest Biotherapeutics Inc (NWBO)

[pgsd]

I have sent the following to the article's main author:-

Dear Marta,

I would like to bring to your attention the following mistakes made in your recently published article, please amend the article and confirm as soon as possible


Maccari et al. state that DCVax-L is “a vaccine composed of autologous dendritic cells loaded with tumor lysate from the patient’s own tumor” (page 2). This is correct, but they do not mention that DCVax-L also contains granulocyte-macrophage colony-stimulating factor (GM-CSF), a cytokine that stimulates the maturation and activation of dendritic cells. Maccari et al. also state that DCVax-L is “administered intradermally every 2 weeks for 3 doses, then every 2 months for 6 doses, and then every 3 months until the vaccine is exhausted” (page 2). This is partially correct, but they omit the fact that DCVax-L is also given intradermally at the time of surgery, before the start of standard of care (SOC) treatment with radiotherapy and temozolomide1. Maccari et al. claim that DCVax-L “showed a median overall survival of 23.1 months in the treated group versus 15.2 months in the control group” (page 2). This is incorrect, as the median overall survival in the treated group was 23.1 months versus 16.6 months in the control group, according to the latest published results. Moreover, they do not specify that the control group received SOC plus placebo, and that some of the control patients crossed over to receive DCVax-L after tumor recurrence1. Maccari et al. also claim that DCVax-L “increased the percentage of long-term survivors (>36 months) from 6.8% to 16.8%” (page 2). This is incorrect, as the percentage of long-term survivors (>36 months) was 16.8% in the treated group versus 5.7% in the control group, according to the latest published results. Liau et al. state that DCVax-L is “a personalized vaccine consisting of autologous dendritic cells loaded with tumor lysate from the patient’s own tumor and granulocyte-macrophage colony-stimulating factor” (page 113). This is correct, and they provide more details about the manufacturing process and the dosing schedule of DCVax-L than Maccari et al. (pages 113-114). Liau et al. also state that DCVax-L “demonstrated a median overall survival of 23.1 months in the treated group versus 16.6 months in the control group” (page 113). This is correct, and they also specify that the control group received SOC plus placebo, and that 64 of the 99 control patients crossed over to receive DCVax-L after tumor recurrence (pages 113-114). Liau et al. also state that DCVax-L “increased the percentage of long-term survivors (>36 months) from 5.7% to 16.8%” (page 113). This is correct, and they also report the survival rates at other time points, such as 24 months, 30 months, and 60 months (pages 113-114).

Also, with regards to the following comment:-

absence of information regarding the stated primary endpoint of the study which was PFS

The endpoints were pre-specified and changed prior to unblinding so PFS was NOT the primary endpoint

Design, Setting, and Participants This phase 3, prospective, externally controlled nonrandomized trial compared overall survival (OS) in patients with newly diagnosed glioblastoma (nGBM) and recurrent glioblastoma (rGBM) treated with DCVax-L plus SOC vs contemporaneous matched external control patients treated with SOC.


https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847