TG1042 (Adenovirus-interferon-γ) in primary cutaneous B-cell lymphomas: a phase II clinical trial

Brigitte Dreno, Mirjana Urosevic-Maiwald, Youn Kim, Joan Guitart, Madeleine Duvic, Olivier Dereure, Amir Khammari, Anne-Chantal Knol, Anna Derbij, Monika Lusky, Isabelle Didillon, Anne-Marie Santoni, Bruce Acres, Vincent Bataille, Marie-Pierre Chenard, Pascal Bleuzen, Jean-Marc Limacher, Reinhard Dummer, Brigitte Dreno, Mirjana Urosevic-Maiwald, Youn Kim, Joan Guitart, Madeleine Duvic, Olivier Dereure, Amir Khammari, Anne-Chantal Knol, Anna Derbij, Monika Lusky, Isabelle Didillon, Anne-Marie Santoni, Bruce Acres, Vincent Bataille, Marie-Pierre Chenard, Pascal Bleuzen, Jean-Marc Limacher, Reinhard Dummer

Abstract

Rational: While a variety of registered therapies exist for Cutaneous T Cell Lymphoma, no such therapy is available for Cutaneous B Cell Therapy. In this context we performed a phase II, open label, multicenter, non-comparative study to evaluate the efficacy and safety of repeated intra-lesional administrations of TG1042 (adenovirus-interferon-γ) in patients with relapsing primary cutaneous B-cell lymphomas (CBCL).

Method: Thirteen patients have been enrolled and received intralesional injections of TG1042 containing 5×10(10) viral particles into up to six lesions simultaneously. Injections were performed on days 1, 8 and 15 of each of four consecutive 28 day cycles.

Results: Eleven (85%) out of 13 enrolled patients showed an objective response after injections of TG1042. Seven patients (54%) exhibited complete and four (31%) displayed partial response. The median time to disease progression in the study population was 23.5 months (range 6.25 to 26+). Most commonly observed adverse events were minor to moderate flu-like symptoms, fatigue and injection site reactions.

Conclusions: Our study showed that treatment with TG1042 was associated with a clinical benefit in the majority of the patients with relapsing CBCL, including tumor regression, a clinically meaningful duration of response and a good treatment tolerance.

Trial registration: www.clinicaltrials.govNCT00394693.

Conflict of interest statement

Competing Interests: The authors have read the journal's policy and have the following conflicts: AD, VB, ML, AMS, ID, VB, BA and JML are employees of Transgene SA and own stocks of the company. This does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials. Other authors have no conflict of interest to disclose.

Figures

Figure 1. Study profile.
Figure 1. Study profile.
Figure 2. Time to Progression TTP).
Figure 2. Time to Progression TTP).
Figure 3. Examples of lesions before and…
Figure 3. Examples of lesions before and after treatment with TG1042.
Patient #2, PCMZL, before treatment (A) and after 7 months (B). Patient #5, PCFCL, before treatment (C) and after 4 months (D). Patient #7, PCFCL, before treatment (E) and after 9 months (F).

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