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TOPAZ-1 is first phase III trial to show immunotherapy combination improves survival in this setting
The combination did not increase discontinuations due to adverse events compared with chemotherapy alone
Positive results from TOPAZ-1 Phase III trial show AstraZeneca’s IMFINZI® (durvalumab) in combination with standard-of-care chemotherapy, as first-line treatment for patients with advanced biliary tract disease, showed statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) compared with chemotherapy alone. Improve Cancer (BTC).
The results will be presented Jan. 21 at the 2022 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancer Symposium.
BTC is a group of rare and aggressive cancers that occur in the bile ducts and gallbladder.1,2 About 50,000 people in the United States, Europe, and Japan, and about 210,000 people worldwide, are diagnosed with BTC each year.3-5 These patients have a poor prognosis, with approximately 5% to 15% of BTC patients surviving five years.6
Do-Youn Oh, MD, PhD, Professor of Medical Oncology, Department of Medicine, Seoul National University Hospital and Seoul National University School of Medicine, Principal Investigator of the TOPAZ-1 Phase III Trial: More than a decade of progress in advanced biliary tract cancer, TOPAZ-1 The results are a huge improvement for our patients, with the addition of IMFINZI to chemotherapy showing a clear survival benefit compared to standard therapy with a significant safety profile. This combination will provide a much-needed and potentially practice-changing new treatment option in a setting where the current prognosis is devastating. ”
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “The results of the TOPAZ-1 trial challenge expectations for the treatment of advanced biliary tract cancer and provide compelling evidence that long-term survival is possible. Overall survival has increased over time. It is estimated that one in four patients with IMFINZI plus chemotherapy survive at two years, compared with one in 10 who received chemotherapy alone. This is a potential new care for patients with this condition standard, we remain committed to making progress in gastrointestinal cancers with a high unmet need.”
In a predefined interim analysis, patients who received IMFINZI in combination with standard-of-care chemotherapy had a 20% lower risk of death compared with chemotherapy alone (based on hazard ratios) [HR] 0.80; 95% confidence interval [CI], 0.66-0.97; 2-sided p = 0.021). Median OS was 12.8 months compared with 11.5 months with chemotherapy. An estimated 25% of patients are alive at two years, compared with 10% of those who received chemotherapy.
Results also showed that IMFINZI plus chemotherapy reduced the risk of disease progression or death by 25% (HR, 0.75; 95% CI, 0.64-0.89; 2-sided p=0.001). The median PFS was 7.2 months with combination therapy and 5.7 months with chemotherapy. The objective response rate (ORR) was 26.7% for patients who received IMFINZI in combination with chemotherapy, compared with 18.7% for patients who received chemotherapy alone.
Summary of efficacy resultsA generation:
|
|
Chinese + chemotherapy (n=341) |
placebo + chemotherapy (n=344) |
|
youtwo, three |
|
|
|
% of patients with an event |
58.1 |
65.7 |
|
Median OS (95% CI) (in months) |
12.8 (11.1, 14.0) |
11.5 (10.1, 12.5) |
|
Human Resources (95% CI)
2-sided p-value |
0.80 (0.66, 0.97)
0.021 |
|
|
OS rate at 18 months (95% CI) (%) |
35.1 (29.1, 41.2) |
25.6 (19.9, 31.7) |
|
OS rate at 24 months (95% CI) (%) |
24.9 (17.9, 32.5) |
10.4 (4.7, 18.8) |
|
PFSfour, five |
|
|
|
% of patients with an event |
80.9 |
86.3 |
|
Median PFS (95% CI) (in months) |
7.2 (6.7, 7.4) |
5.7 (5.6, 6.7) |
|
Human Resources (95% CI)
2-sided p-value |
0.75 (0.64, 0.89)
0.001 |
|
|
ORR (%) |
26.7 |
18.7 |
|
A generation. |
Analysis was performed at an OS data maturity of 62%. |
|
|
ii. |
The OS data cutoff date for investigator assessment was August 11, 2021. |
|
|
iii. |
Median follow-up for patients reviewed by DCO was 13.7 months (range 0.4-27.2) with IMFINZI plus chemotherapy and 12.6 months (range 0.7-26.0) with chemotherapy alone. |
|
|
iv. |
The PFS data cutoff date for investigator assessment was August 11, 2021. |
|
|
five. |
Median follow-up for patients reviewed by DCO was 9.2 months (range 0.0-24.0) with IMFINZI plus chemotherapy and 6.9 months (range 0.0-20.4) with chemotherapy alone. |
Compared with chemotherapy alone, IMFINZI in combination with chemotherapy did not increase the rate of discontinuation due to adverse events (AEs). Grade 3 or 4 treatment-related AEs were experienced by 62.7% of patients receiving IMFINZI and chemotherapy and 64.9% of patients receiving chemotherapy alone. Treatment-related AEs led to discontinuation in 8.9% of patients receiving the IMFINZI combination versus 11.4% of patients receiving chemotherapy.
In December 2020, IMFINZI received orphan drug designation in the United States for the treatment of BTC.exist October 2021, an independent data monitoring committee recommended that the TOPAZ-1 phase III trial be unblinded at the interim analysis because of clear evidence of the efficacy of IMFINZI plus chemotherapy.
Another presentation during the ASCO Gastrointestinal Cancer Symposium will present IMFINZI data…
The full story is available on Benzinga.com
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