Heron Therapeutics Announces Positive Results from Phase 3 MAGIC Study of SUSTOL®
-Primary endpoint achieved
-SUSTOL, as part of a three-drug regimen, is the first 5-HT3 antagonist to demonstrate superiority to standard-of-care for delayed nausea and vomiting after HEC
-SUSTOL-based regimen was associated with significantly reduced nausea and improved patient satisfaction
-Conference call and webcast
The MAGIC study is the only Phase 3 CINV prophylaxis study in a HEC population performed to-date to use as a comparator the currently recommended, standard-of-care, three-drug regimen: a 5-HT3 receptor antagonist (in this case ondansetron), fosaprepitant and dexamethasone. The study was conducted entirely in the U.S. and enrolled over 900 patients undergoing HEC treatment for various tumor types.
The primary endpoint in this study was the proportion of patients who achieved a Complete Response, defined as no emesis and no rescue medications during the delayed-onset phase of CINV, occurring 24-120 hours following administration of HEC agents. The study’s major efficacy findings include:
- The study’s primary endpoint was achieved. The percentage of patients who achieved a Complete Response was significantly higher in the SUSTOL group than the comparator group (64.7% vs. 56.6%, p=0.014).
- The percentage of patients who achieved Complete Control, defined as Complete Response plus no more than mild nausea during the delayed-onset phase, also reached statistical significance in favor of SUSTOL (p = 0.022).
- The percentage of patients who experienced no nausea or infrequent nausea during the delayed-onset phase was significantly higher in the SUSTOL arm compared with the comparator arm (p = 0.032).
- Significantly more patients in the SUSTOL arm were satisfied with their therapy based on a quality-of-life questionnaire (p = 0.040).
SUSTOL was well tolerated, with no clinically significant differences in the rate or severity of adverse events between the SUSTOL arm and the comparator arm. Injection site reactions observed were consistent with previous trials and generally considered mild, as were the majority of adverse events observed in the study.
“The MAGIC study demonstrated that use of SUSTOL with an NK1
receptor antagonist and dexamethasone for patients receiving HEC
significantly reduced symptoms of CINV. It is significant that both arms
of the study had a three-drug prophylactic regimen, which has not been
previously evaluated in prior Phase 3 trials in this high-risk patient
group. Symptom management in patients receiving cancer treatment
represents a significant unmet medical need, and the results of this
study represent another step forward in this important clinical space,”
“The substantial benefit observed with SUSTOL in Complete Response,
nausea and overall satisfaction with therapy is all the more impressive
given the comparator was a three-drug, standard-of-care regimen. Also,
unlike previous CINV studies, all patients in the MAGIC trial came from
U.S.-based community oncology centers, so the results are highly
representative of what we would expect to see in our patients,” stated
“We are extremely gratified to report that SUSTOL is the first 5-HT3
receptor antagonist to demonstrate a statistically significant
improvement in delayed nausea and vomiting in patients receiving HEC. As
the first large clinical study to compare two three-drug regimens using
the definition for HEC in the 2011
Conference Call and Webcast
About the MAGIC Study
The MAGIC (Modified Absorption Granisetron In
the Prevention of Chemotherapy-Induced Nausea and Vomiting) study
is a prospective, randomized, placebo-controlled, two-arm, Phase 3 study
that randomized 942 patients undergoing highly emetogenic chemotherapy
(HEC) treatment for various tumor types. HEC regimens were defined by
About SUSTOL® for Chemotherapy-Induced Nausea and Vomiting
Heron’s lead investigational product candidate, SUSTOL®
(granisetron injection, extended release), is being developed for the
prevention of both acute- and delayed-onset chemotherapy-induced nausea
and vomiting (CINV) following the administration of moderately
emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC)
agents. SUSTOL is not approved by the
SUSTOL was the subject of a recently completed, multi-center,
placebo-controlled, Phase 3 study in patients receiving HEC agents known
as MAGIC. MAGIC evaluated the efficacy and safety of SUSTOL as part of a
three-drug regimen with the intravenous (IV) neurokinin-1 (NK1)
receptor antagonist fosaprepitant and the IV corticosteroid
dexamethasone for the prevention of delayed nausea and vomiting in
patients receiving HEC. MAGIC, which was conducted entirely in the U.S.,
is the only Phase 3 CINV study to-date to use as a comparator the
currently recommended, standard-of-care, three-drug regimen for CINV
prophylaxis in a HEC population: a 5-HT3 receptor antagonist
(in this case ondansetron), fosaprepitant and dexamethasone. The study’s
primary endpoint was achieved. Specifically, the percentage of patients
who achieved a Complete Response was significantly higher in the SUSTOL
arm compared with the comparator arm (p=0.014). Heron intends to
resubmit its New Drug Application (NDA) for SUSTOL to the
About HTX-019 for Chemotherapy Induced Nausea and Vomiting
HTX-019 is a proprietary intravenous formulation of aprepitant, a neurokinin-1 (NK1) receptor antagonist for the prevention of CINV. NK1 receptor antagonists are typically used in combination with 5-HT3 receptor antagonists. At present, the only injectable NK1 receptor antagonist approved in the U.S. contains polysorbate 80, a surfactant, which may cause hypersensitivity reactions, infusion site reactions or other adverse reactions in some patients. Heron’s formulation for HTX-019 does not contain polysorbate 80 and may have a lower incidence of certain types of adverse reactions than reported with the commercially available injectable NK1 receptor antagonist. Heron intends to file an NDA for HTX-019 using the 505(b)(2) pathway in the second half of 2016.
This news release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995.
Heron Therapeutics, Inc.
Investor Relations Contact:
Jennifer Capuzelo, Sr. Manager, 858-703-6063
Barry D. Quart, Pharm D., 650-366-2626
Chief Executive Officer