For all patients in the 2L Depatux-M + CT arm, the 6-month PFS estimate by central review was 25.6% (95% CI 11.4-42.6) with a median PFS of 2.1 months (95% CI 1.9-3.9; Figure 3 A, B). The 6-month OS estimate was 89.7% (95% CI 71.3-96.5), and the median OS was 14.7 months (95% CI 10.7-15.4; Figure 4). ORR, analyzed in patients with at least one measurable disease at baseline, was 21.7% (5/23) by central review with all responses being PR and the median DoR was 5.5 months (95% CI 1.9-NE; Table 6). Seven patients were considered to have 6-month PFS by investigator review, but not by central review.

For all patients in the 2L Depatux-M + CT arm, the 6-month PFS estimate by central review was 25.6% (95% CI 11.4-42.6) with a median PFS of 2.1 months (95% CI 1.9-3.9; Figure 3 A, B). The 6-month OS estimate was 89.7% (95% CI 71.3-96.5), and the median OS was 14.7 months (95% CI 10.7-15.4; Figure 4). ORR, analyzed in patients with at least one measurable disease at baseline, was 21.7% (5/23) by central review with all responses being PR and the median DoR was 5.5 months (95% CI 1.9-NE; Table 6). Seven patients were considered to have 6-month PFS by investigator review, but not by central review.

For all patients in the 2L Depatux-M + CT arm, the 6-month PFS estimate by central review was 25.6% (95% CI 11.4-42.6) with a median PFS of 2.1 months (95% CI 1.9-3.9; Figure 3 A, B). The 6-month OS estimate was 89.7% (95% CI 71.3-96.5), and the median OS was 14.7 months (95% CI 10.7-15.4; Figure 4). ORR, analyzed in patients with at least one measurable disease at baseline, was 21.7% (5/23) by central review with all responses being PR and the median DoR was 5.5 months (95% CI 1.9-NE; Table 6). Seven patients were considered to have 6-month PFS by investigator review, but not by central review.

intravenous administration (1.25 mg/kg or 1.0 mg/kg body weight) over 30 to 40 minutes once every 2 weeks until one of the treatment withdrawal criteria was met. The dose was 1.25 mg/kg in the original protocol (Version 1) and Version 2, Amendment 1, and was lowered to 1.0 mg/kg in protocol Version 3, Amendment 2. Pediatric participants: Intravenous administration (1.0 mg/kg body weight for those who were 6 to 17 years old at the date of first dose, or 1.3 mg/kg for those who were 0 to 5 years old) over 30 to 40 minutes or as directed by the guidelines once every 2 weeks until one of the treatment withdrawal criteria was met, for a maximum of one year. If used in combination with temozolomide, depatuxizumab mafodotin was dosed on Day 1 and Day 15 of the TMZ cycle (assuming a standard regimen of 200 mg/m^2/day for 5 days of each 28-day cycle; for other TMZ schedules, timing of the depatuxizumab mafodotin dosing schedule were to be discussed with the medical monitor).

During the Chemoradiation Phase, participants were to receive depatuxizumab mafodotin at 2.0 mg/kg IV infusion over 30 - 40 minutes once every 2 weeks (Day 1 of Weeks 1, 3, and 5 of the 6-week regimen). During the Adjuvant Therapy Phase, participants were to receive depatuxizumab mafodotin at 1.25 mg/kg on Day 1 (± 2 days) and Day 15 (± 2 days) of each 28-day cycle as a 30 - 40 minute infusion for 12 cycles.

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to ABT-414 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.