Electroporation via OMS was performed immediately following intratumoral injection of tavo. A sterile applicator containing 6 stainless steel electrodes arranged in a circle were placed around the tumor. The applicator was connected to the OMS power supply and six pulses were administered to each tumor lesion at the approximate point of tavo injection.

Overall survival (OS) time is defined as the duration between the date of treatment initiation (Study Day 1) to the date of death, regardless of the cause of death, assessed up to 30 months.

ORR is defined as the percentage of participants with evaluable lesions that achieved a complete response (CR) or partial response (PR) as assessed by the investigator using irRC criteria. CR: complete disappearance of all lesions (whether measurable or not) and the absence of new lesions for at least 4 weeks duration, confirmed by additional scan and visit 4 to 6 weeks after first documentation of CR. PR: ≥50% decrease in the product of the diameters from baseline.

Duration of objective response (CR or PR based on Modified RECIST criteria) is defined as the number of days from the initial documentation of an objective response to the most current evaluation of that response or to documentation of progression or death associated with disease progression. CR: complete disappearance of all lesions (whether measurable or not) and the absence of new lesions for at least 4 weeks duration, confirmed by additional scan and visit 4 to 6 weeks after first documentation of CR. PR: ≥30% decrease in longest dimension (LD) from baseline lesion, and no new lesions. Patients who had an initial response and did not progress were censored at their date of last assessment.

Time to objective response (CR or PR based on Modified RECIST criteria) is defined as the number of days between the date of treatment initiation (Study Day 1) to the first date of the first documentation of an objective response. CR: complete disappearance of all lesions (whether measurable or not) and the absence of new lesions for at least 4 weeks duration, confirmed by additional scan and visit 4 to 6 weeks after first documentation of CR. PR: ≥30% decrease in longest dimension (LD) from baseline lesion, and no new lesions. Patients who had an initial response and did not progress were censored at their date of last assessment. Patients who did not have an objective response were censored at their date of last assessment.

Progression free survival (PFS) is defined as the duration between the date of treatment initiation (Study Day 1) to the first date of either disease progression at either local or distant sites, or death from any cause. Disease progression at local or distant lesions is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Patients were censored at their last assessment date if there was no evidence of disease progression.

The treated (injected, electroporated) lesion regression rate is defined as the percentage of patients who had at least one treated lesion that decreased in longest dimension by ≥ 30%. The untreated (non-injected, non-electroporated) lesion regression rate is defined as the percentage of patients who had at least one untreated lesion that decreased in longest dimension by ≥ 30%.

Patients received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 6-week intervals until disease progression or unacceptable toxicity for up to 2 cycles.

Total of all reporting groups

Patients received one cycle (3 daily treatments on Days 1, 8, and 15) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 6-week intervals until disease progression or unacceptable toxicity for up to 9 cycles.

Patients received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 6-week intervals until disease progression or unacceptable toxicity for up to 2 cycles.

An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, medical treatment or procedure and which did not necessarily have to have had a causal relationship with this treatment. An adverse event could have, therefore, been any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, medical treatment or procedure whether or not considered related to the medicinal product. An SAE was defined an any untoward medical occurrence that at any dosage resulted in one or more of the following: death, A life-threatening adverse event (real risk of dying), inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly, required intervention to prevent permanent impairment of damage.

Safety Analysis Set, all patients who were enrolled and received any amount of the study treatment (pIL-12).

Overall survival (OS) time is defined as the duration between the date of treatment initiation (Study Day 1) to the date of death, regardless of the cause of death, assessed up to 30 months.

Efficacy Analysis Set, all enrolled patients who received at least one full cycle of study treatment and had at least one efficacy assessment following the first dose of study drug. Patients were censored at the last date that they were known to be alive.

ORR is defined as the percentage of participants with evaluable lesions that achieved a complete response (CR) or partial response (PR) as assessed by the investigator using irRC criteria. CR: complete disappearance of all lesions (whether measurable or not) and the absence of new lesions for at least 4 weeks duration, confirmed by additional scan and visit 4 to 6 weeks after first documentation of CR. PR: ≥50% decrease in the product of the diameters from baseline.

Efficacy Analysis Set, all enrolled patients who received at least one full cycle of study treatment and had at least one efficacy assessment following the first dose of study drug, who had at least one post-baseline response assessment.

Duration of objective response (CR or PR based on Modified RECIST criteria) is defined as the number of days from the initial documentation of an objective response to the most current evaluation of that response or to documentation of progression or death associated with disease progression. CR: complete disappearance of all lesions (whether measurable or not) and the absence of new lesions for at least 4 weeks duration, confirmed by additional scan and visit 4 to 6 weeks after first documentation of CR. PR: ≥30% decrease in longest dimension (LD) from baseline lesion, and no new lesions. Patients who had an initial response and did not progress were censored at their date of last assessment.

Efficacy Analysis Set, all enrolled patients who received at least one full cycle of study treatment and had at least one efficacy assessment following the first dose of study drug, who had at least one post-baseline response assessment and had a CR or PR.

Time to objective response (CR or PR based on Modified RECIST criteria) is defined as the number of days between the date of treatment initiation (Study Day 1) to the first date of the first documentation of an objective response. CR: complete disappearance of all lesions (whether measurable or not) and the absence of new lesions for at least 4 weeks duration, confirmed by additional scan and visit 4 to 6 weeks after first documentation of CR. PR: ≥30% decrease in longest dimension (LD) from baseline lesion, and no new lesions. Patients who had an initial response and did not progress were censored at their date of last assessment. Patients who did not have an objective response were censored at their date of last assessment.

Efficacy Analysis Set, all enrolled patients who received at least one full cycle of study treatment and had at least one efficacy assessment following the first dose of study drug, who had at least one post-baseline response assessment and had a CR or PR.

Progression free survival (PFS) is defined as the duration between the date of treatment initiation (Study Day 1) to the first date of either disease progression at either local or distant sites, or death from any cause. Disease progression at local or distant lesions is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Patients were censored at their last assessment date if there was no evidence of disease progression.

Efficacy Analysis Set, all enrolled patients who received at least one full cycle of study treatment and had at least one efficacy assessment following the first dose of study drug, who had at least one post-baseline response assessment and had a CR or PR based on Modified RECIST criteria.

The treated (injected, electroporated) lesion regression rate is defined as the percentage of patients who had at least one treated lesion that decreased in longest dimension by ≥ 30%. The untreated (non-injected, non-electroporated) lesion regression rate is defined as the percentage of patients who had at least one untreated lesion that decreased in longest dimension by ≥ 30%.

Efficacy Analysis Set, all enrolled patients who received at least one full cycle of study treatment and had at least one efficacy assessment following the first dose of study drug.

Patients received one cycle (3 daily treatments on Days 1, 8, and 15) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 6-week intervals until disease progression or unacceptable toxicity for up to 9 cycles.

Patients received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation. Treatment could be repeated at 6-week intervals until disease progression or unacceptable toxicity for up to 2 cycles.