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Table 2 Overview of AXAL in clinical studies (safety and efficacy)

From: Therapeutic options for treatment of human papillomavirus-associated cancers - novel immunologic vaccines: ADXS11–001

Cancer type Cancer stage Investigator Study phase (stage; NCT) Mono−/Multi-therapy Dosing regimen Estimated enrollment Efficacy Safety (most frequent AEs)
Cervical cancer Advanced Maciag PC I
(60)
AXAL alone Dose escalation
• 1 × 109 CFU
• 3.3 × 109 CFU
• 1 × 1010 CFU
15 • Possible PR: 1 patient
• SD: 7 patients
• Progression of disease: 5 patients
• Pyrexia (100%)
• Vomiting (60%)
• Musculoskeletal pain (57%)
• Chills; headache and anemia (53%)
• Nausea and tachycardia (47%)
DLT = 1 × 1010 CFU
Persistent/recurrent/metastatic GOG
(Huh WK)
II
(stage 1; NCT01266460)
(62)
AXAL alone 1 × 109 CFU 67 • 12-month OS: 38.5%
• Median PFS: 3.1 mo
• Median OS: 7.7 mo
• PR: 1 patient
• SD: 9 patients
Drug-related AEs (38% of all AEs)
• Vomiting
• Chills
• Fatigue
• Fever
Persistent/recurrent/metastatic Ghamande SA I-II
(TiP; NCT02164461)
(63)
AXAL alone Dose escalation
• 5 × 109 CFU
• 1 × 1010 CFU
25 Pending Treatment-related AEs (>3 patients)
• Chills
• Vomiting
• Hypotension
• Tachycardia
• Fever
• Nausea
Recurrent/refractory Petit R II
(CTRI/2010/091/001232)
(64)
AXAL ± cisplatin 1 × 109 CFU + 40 mg/m2 110 • 12-mo OS: 36%
• 18-mo survival: 28%
• Response rate: 11% (6 CRs; 6 PRs)
• SD: 35 patients
• 79% of AEs: mild or moderate and unrelated to study drug
High-risk locally advanced GOG
(Herzog TJ)
III
(TiP; NCT02853604) (65)
AXAL alone 1 × 109 CFU 450 Pending Pending
Head and neck cancer Persistent/recurrent/metastatic Cohen EW I/II
(TiP; NCT02291055)
(66)
AXAL ± MEDI4736 Phase I: 1 × 109 CFU +
3 mg/kg (3 + 3 design for MEDI4736 dose escalation)
Phase II: 1 × 109 CFU + 10 mg/kg
66 Pending Pending
Previously untreated, surgically resectable, stage II–IV patients (oropharyngeal cancer) Miles B and Sikora A II
(NCT02002182)
(67)
AXAL + transoral robotic surgery 1 × 109 CFU 30 (present time: 8/9 vaccinated patients;
10 observational group patients)
• Increased Ag-specific IFN-γ (5/8) or TNF-α (78) responses at 3/5 time points (other 2 time points pending)
• Intratumoral expression of CD8 (4/8), PD-1 (6/8)
Pending
Oropharyngeal cancer Jones TM I
(NCT01598792)
(68)
AXAL alone Dose escalation
• 3.3 × 108 CFU
• 1 × 109 CFU
• 3.3 × 109 CFU
36 Pending Pending
Anal cancer Locally advanced Safran H I/II
(TiP; NCT01671488)
(69)
AXAL ± chemo-radiation (mitomycin, 5-fluorouracil, IMRT) 1 × 109 CFU 25 Pending Pending
Persistent/recurrent, locoregional/metastatic anorectal canal Fakih M II
(stage 2 TiP; NCT02399813)
(70)
AXAL alone 1 × 109 CFU Stage 1
• 31 patients
Stage 2
• 24 patients
Pending Pending
  1. Ag antigen, BID bi-daily, CR complete response, CTRI Clinical Trials Registry – India, DLT dose-limiting toxicity, IMRT intensity-modulated radiation therapy, NCT National Clinical Trial, PR partial response, SAE serious adverse event, TiP trial in progress