Update on the results of the Phase II trial of Camidanlumab Tesirine in relapsed/refractory classic Hodgkin lymphoma: both overall and complete response rates have increased!

• Baseline characteristics of the patient

The median age of patients was 37 years (range: 19-87), 62.
4% were male, and 95% had an ECOG score of 0-1
.
The baseline characteristics of patients are shown in Table 1
.

Table 1 Baseline characteristics of patients

• efficacy

Patients treated with Cami had an ORR of 70.
1% (82/117, 95% CI 60.
9–78.
2) and a CR rate of 33.
3% (39/117) (Figure 2).

Fig.
2 Patient remission

Due to protocol deviations, one patient was not treated
with vebutuximab.
Of the remaining 116 patients, the optimal ORR was 74.
0% (95% CI 62.
4-83.
5) for those who had received hematopoietic stem cell transplantation (HSCT) and 62.
8% (95% CI 46.
7-77.
0) for those who had not received HSCT (Table 2).

Table 2 Best ORR for patients receiving and not receiving HSCT

The median treatment period for all patients was 5 (range: 1-15) and the median duration of treatment was 85 days (range: 1-330).

Most remissions occurred after 2 treatment cycles, with 15 patients who initially achieved PR subsequently reaching CR (Figure 3).

Fourteen patients stopped treatment in preparation for HSCT, and 12 of them eventually underwent HSCT.

Fig.
3 Efficacy results of patients receiving long-term treatment with Cami

The median follow-up was 10.
7 months (range: 1.
2–25.
2+), with a median DOR of 13.
7 months (95% CI 7.
4–14.
7) for all patients, a median DOR of 14.
5 months (95% CI 7.
4–NR) for patients achieving CR, and 7.
9 months (95% CI 3.
8-NR) for patients achieving partial response (PR) (Figure 4).

Fig.
4 DOR of patients treated with Cami

The median PFS in patients treated with Cami was 9.
1 months (95% CI 5.
1–15.
0) (Figure 5).

Fig.
5 PFS of patients receiving Cami-treatment

• security

Adverse events (TEAEs) during treatment of any grade (≥ 25% of patients) included fatigue (38.
5%), maculopapular rash (32.
5%), fever (29.
9%), nausea (27.
4%), and rash (26.
5%) (Table 3).

Grade ≥ 3 TEAE (≥5% of patients) included thrombocytopenia (9.
4%), anemia (8.
5%), hypophosphatemia (7.
7%), neutropenia (7.
7%), maculopapular rash (6.
8%), and lymphopenia (5.
1%)
.

Table 3 TEAE of all patients

Thirty-eight (32.
5%) patients developed immune-related TEAE
.
Grade 3 immune-related adverse events (ir-AEs) occurred in 10 ≥patients, with a median age of 45.
5 years (range: 22-75) in 10 patients, of whom 8 had undergone auto-HSCT (Table 4).

The median CMI treatment cycle was 3.
5 (range: 2-12), and 50% of ≥ grade 3 ir-AEs occurred after 2-3 Cami treatment cycles and 50% occurred 30 days after
the last Cami dose.

Table 4 Patients with ir-AE

Eight (6.
8%) patients developed Guillain-Barré syndrome (GBS)/polyradiculopathy, and the median age of eight patients was 35 years (range: 23-68), of which three had undergone HSCT (Table 5).

The median CMI treatment cycle was 3.
5 (range: 2-7), with 4 GBS/polyradiculopathy occurring after 2 treatment cycles and 3 GBS/polyradiculopathy occurring 30 days after
the last Cami administration.

Table 5 Patients with GBS/polyradiculopathy