Innovent Biologics has revealed Phase I results of IBI322, a recombinant anti-human CD47/PD-L1 bispecific antibody, to treat anti-PD-(L)1-resistant patients with classic Hodgkin lymphoma.

The results were supported by a dose-expansion cohort from a Phase I trial aiming to assess the preliminary antitumor activity and safety of IBI322 in these patients.

During the trial, the patients were treated with IBI322 until unacceptable toxicity or disease progression, or up to a period of 24 months.

Out of the 24 patients currently enrolled in the trial, 23 were reported to be efficacy evaluable.

The objective response rate (ORR) was 47.8% and the disease control rate (DCR) was 91.3% among the 23 patients.

The ORR touched as high as 57.1% in the seven patients with primary resistance, while three patients attained complete response (CR).

Regarding safety, the incidence of treatment-related adverse reactions (TRAE) was 91.7%. The most common TRAE were decreased lymphocyte count, which was 62.5%, and anaemia, which was also 62.5%.

The decreased white blood cell count and decreased platelet count were 20.8% and 20.8%, respectively.

Furthermore, the event of grade ≥ 3 TRAE was 41.7%, with the most common ≥ grade 3 TRAE more than 5% associated with decreased lymphocyte count being 29.2%.

No TRAE resulting in permanent treatment discontinuation or death was reported in the trial.

Until the trial’s data cut-off, 12 patients were still treated with IBI322 monotherapy.

Overall, IBI322 monotherapy demonstrated encouraging anti-tumour efficacy with a manageable safety profile in the targeted patients.

West China Hospital of Sichuan University professor and the trial’s principal investigator Ting Niu said: “This phase I study shows that IBI322 monotherapy is effective and safe in the treatment of PD-1 or PD-L1 treatment-resistant classical Hodgkin lymphoma, and we look forward to longer follow-up results and larger sample sizes in the future.

“IBI322 has the potential to be an effective treatment option for the treatment of immunotherapy-resistant classical Hodgkin lymphoma and other types of lymphoma to meet the unmet clinical needs.”