Ongoing discussion around
$NWBO and
$IBRX, especially after
@maveric92283613 post, warrants clarity on what Dr. Makary actually said and what he was pointing to:
“I’d like to see more cancer therapies that apply to stage 4 metastatic disease, and cancer therapies that result in what we call, in medicine, a complete pathologic response. That is, the cancer melts away… eliminated without chemo, surgery, or radiation therapy.”
Makary wasn’t speculating. He referenced therapies already in the pipeline.
And his language, “eliminated without chemo, surgery, or radiation,” didn’t just describe efficacy.
It implied safety: tumor clearance without exposing patients to the toxicity of conventional treatment.
Let’s examine what’s on record:
🧬 Anktiva in GBM (QUILT 3.078 / NCT06061809)
Combination therapy
•Anktiva (N 803)
•PD L1 t haNK
•Bevacizumab (Avastin)
Context
•No chemo or radiation, but Avastin is not low risk
•Carries FDA black box warnings:
•GI perforation
•Arterial thromboembolism
•Wound healing failure
•CNS hemorrhage
avastin.com/hcp/safety.html
•In GBM specifically, Avastin failed to improve overall survival in randomized trials and is used for symptom control only
cancer.gov/about-cancer/trea…
There is no published monotherapy data showing tumor elimination or systemic regression in stage 4 solid tumors with Anktiva.
Trial registry:
clinicaltrials.gov/study/NCT…
🧬 DCVax Direct (NCT01882946)
Patient population
•Stage 4, metastatic, inoperable
•All had failed standard therapies
Protocol
•No chemo
•No radiation
•No surgery
•Only one lesion injected
•Uninjected tumors regressed
Outcomes
•Most common side effect: mild fever under 48 hours
•Covered 13 advanced solid tumor types
•Trial data published in Frontiers in Oncology (2018):
frontiersin.org/articles/10.…
•Updated and presented by Dr. Marnix Bosch at NYAS 2025
NYAS Slide Source:
nwbio.com/wp-content/uploads…
ClinicalTrials.gov:
clinicaltrials.gov/study/NCT…
Mechanistic evidence
“TILs sharing sequences with peripheral T cells increased, indicating a systemic response.” Dr. Marnix Bosch
Clarification: These were naturally activated TILs, induced in vivo by dendritic cell injection alone, not adoptively transferred or lab expanded. Importantly, no booster agents, immune modulators, lymphodepletion, or preconditioning were used. The systemic response was uncalibrated and unassisted.
Systemic immune activation, without chemo, radiation, or adjuncts like Avastin.
Clinical outcomes observed, not theorized.
🧠 Makary described exactly this:
Stage 4. Tumor melt. No chemo. No radiation. No surgery. Low toxicity.
That’s DCVax Direct. It is the only known published match.
🔍 What About Other Therapies?
We searched
ClinicalTrials.gov, Nature, NCBI, GSK pipelines, Mass General reports, and FDA archives for any therapy with equivalent results.
❌ CAR T in GBM (Mass General, INCIPIENT trial)
•Regression in 3 patients
•Not durable; tumors recurred
•No systemic clearance confirmed
Trial:
clinicaltrials.gov/study/NCT…
Press release:
massgeneral.org/news/press-r…
❌ TIL Therapy in Melanoma
•Durable responses in some patients
•Requires toxic lymphodepletion plus IL 2
•Limited to immunogenic tumors (melanoma)
FDA approval of lifileucel:
fda.gov/drugs/news-events-hu…
❌ Dostarlimab (GSK) in Rectal Cancer
•100 percent complete response in dMMR patients
•But in non metastatic, locally advanced disease
•Not applicable to Makary’s “stage 4” standard
GSK trial data:
nature.com/articles/s41591-0…
None of these meet the full clinical profile Makary outlined.
🧩 The Clinical Bar Has Been Set
Makary described a real immunologic phenomenon:
•In stage 4 disease
•Without chemo, surgery, or radiation
•With confirmed systemic tumor regression
•And without toxicity
Only DCVax Direct demonstrates this, across tumor types, in human subjects, with published survival benefit and immune data.
If anyone knows of a therapy that meets this standard more precisely, with public data, you are invited to present it.
At this point, the case is not just made, it remains unchallenged.
#DCVax #Murcidencel #Stage4 #TumorMelt #CompleteResponse #NoChemo #NoRadiation #NoSurgery #NoToxicity #SystemicImmunity #ImmuneActivation #PublishedData #Immunotherapy #GBM #ClinicalTrials #OpenChallenge @DrMakaryFDA