Tanovea-CA1: Product Information (Page 4 of 5)

EFFECTIVENESS:

The effectiveness and safety of TANOVEA (rabacfosadine for injection) for the treatment of lymphoma was evaluated in a randomized, placebo-controlled, masked, multicenter clinical field study. TANOVEA was compared to placebo (saline) using progression free survival (PFS) as the primary endpoint. PFS was defined as the interval between the date of randomization and the first date that criteria for progressive disease were met, or the date of death, whichever occurred first. Response assessments were made according to the Veterinary Cooperative Oncology Group Response Evaluation Criteria for Peripheral Nodal Lymphoma in Dogs.2 The study enrolled dogs of any breed, except West Highland White Terrier, or any sex diagnosed with multicentric lymphoma with at least one measurable peripheral lymph node.

One hundred and fifty-eight dogs were randomly assigned to treatment with either 1 mg/kg TANOVEA (n=120) or placebo (n=38) as a 30-minute intravenous infusion, once every three weeks for five doses, or until disease progression or withdrawal from the study for another cause. Dose delays of up to 14 days or stepwise dose reductions to 0.8 mg/kg and 0.66 mg/kg were allowed to manage adverse reactions. Effectiveness was evaluated in 148 dogs (112 in the TANOVEA group and 36 in the placebo control group).

The effectiveness analysis demonstrated a statistically significantly longer median PFS (P <0.0001) in dogs administered TANOVEA compared to placebo (82 days vs. 21 days, respectively).

The median PFS was 151 days in dogs in the TANOVEA group that exhibited a partial response (PR) or complete response (CR) and 168 days for dogs with a CR. The best overall response rate (BORR; the percent of dogs with a PR or CR as their highest response on study) was 73.2% (82/112 dogs) for dogs in the TANOVEA group (50.9% CR; 57/112 dogs) vs. 5.6% (2/36 dogs) for dogs in the placebo group (0% CR; 0/36 dogs).

For dogs with B-cell lymphoma, the median PFS was greater for dogs in the TANOVEA group compared to dogs in the placebo group (126 vs. 21 days, respectively). A smaller trend was observed for dogs with T-cell lymphoma (29 vs. 17 days, respectively). In the TANOVEA group, the BORR was 80.4% (74/92 dogs) in dogs with B-cell lymphoma (58.7% CR; 54/92 dogs), and 40.0% (8/20 dogs) in dogs with T-cell lymphoma (15.0% CR; 3/20 dogs).

For dogs naïve to prior chemotherapy regimens, the median PFS was greater for dogs in the TANOVEA group compared to dogs in the placebo group (143 vs. 19 days, respectively), with a shorter duration of PFS observed for dogs that had received prior chemotherapy (63 vs. 21 days, respectively). Dogs in the TANOVEA group with one prior chemotherapy had a median PFS of 82 days (127 days in dogs with a response to treatment). Dogs with B-cell lymphoma in the TANOVEA group with one prior chemotherapy regimen had a median PFS of 107 days (172 days in dogs with a response to treatment). Dogs with T-cell lymphoma in the TANOVEA group with one prior chemotherapy regimen had a median PFS of 21 days.

The BORR in dogs in the TANOVEA group were impacted by the number of prior chemotherapy regimens, with a BORR of 88.7% (47/53 dogs) in naïve dogs (62.3% CR; 33/53 dogs), 70.3% (26/37 dogs) in dogs with one prior chemotherapy regimen (54.1% CR; 20/37 dogs), and 40.9% (9/22 dogs) in dogs with more than one prior chemotherapy regimen (18.2% CR; 4/22 dogs).

See Table 3 below for a response summary in TANOVEA treated dogs.

Table 3. Response Summary in TANOVEA-Treated Dogs

a Refers to number of prior chemotherapy regimens (e.g., 0, 1, >1)

b N/A: Not applicable. Includes one dog with a PFS of 43 days

c N/A: Not applicable. Includes one dog with a PFS of 60 days

d NE: Not estimable. Includes four dogs with PFS of 50, 63, 161, and 360 days

e NO: No observations

Overall B-cell T-cell Naive 1 prior a >1 priora 1 prior (B- cell)a 1 prior (T- cell)a >1 prior (B- cell)a >1prior(T-
cell)a
n 112 92 20 53 37 22 30 7 18 4
Median PFS (days) 82 126 29 143 82 41 107 21 39 60
Median PFS (responding dogs) 151 161 55 160 127 64 172 N/Ab 64 N/Ac
Median PFS (CR only) 168 168 63 168 172 NEd 172 N/Ab NEd NOe
% BORR 73.2 80.4 40 88.7 70.3 40.9 83.3 14.3 44.4 25
% CR (anytime) 50.9 58.7 15 62.3 54.1 18.2 63.3 14.3 22.2 0
% PR (anytime) 22.3 21.7 25 26.4 16.2 22.7 20 0 22.2 25

At the time of the Day 112 visit (one month after the last treatment), 33.0% (37/112 dogs) of dogs in the TANOVEA group were progression free compared with 0 (0/36 dogs) placebo dogs. Forty-four TANOVEA dogs completed five cycles of treatment, and five dogs had a CR at Day 365 (study end). Only one placebo dog completed five cycles and no placebo dogs achieved a CR. The primary reason for early withdrawal from the study for all dogs in both groups was disease progression, followed by death and adverse reactions.

Concomitant medications were used primarily for diarrhea, decreased appetite, and dermatopathy (bacterial skin infections). The most commonly used concomitant medications included antiemetics, antibiotics, electrolyte solutions, sedatives, appetite stimulants, analgesics, and topical corticosteroids with anti-infectives. No other chemotherapies or systemic corticosteroids were used in the study.

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