Ipsen presents Phase III NAPOLI 3 trial of Onivyde® regimen demonstrating positive survival results in previously untreated metastatic pancreatic ductal adenocarcinoma at ASCO GI

  • Investigational Onivyde® (irinotecan liposome injection) in the NALIRIFOX treatment regimen demonstrated statistically significant improvements in overall survival and progression-free survival compared to nab-paclitaxel plus gemcitabine with a manageable safety profile1
  • Results represent a potential advance in an aggressive and difficult-to-treat cancer
  • Ipsen plans to file a supplemental New Drug Application with the U.S. Food and Drug Administration

PARIS, FRANCE I January 20, 2023 I Ipsen (Euronext: IPN; ADR: IPSEY) today presented positive results from the pivotal Phase III NAPOLI 3 trial evaluating an investigational regimen of Onivyde® (irinotecan liposome injection), a long-circulating, liposomal topoisomerase inhibitor, in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). In a late-breaking abstracts session presentation (LBA661) at the 2023 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, the data demonstrating investigational novel NALIRIFOX regimen (liposomal irinotecan 50 mg/m2 + 5-FU 2400 mg/m2 + leucovorin 400 mg/m2 + oxaliplatin 60 mg/m2) improved overall survival (OS) and progression-free survival (PFS) compared to nab-paclitaxel plus gemcitabine.1 At the median follow-up of 16.1 months, the investigational Onivyde regimen met its primary endpoint demonstrating a statistically significant improvement in OS of 11.1 months compared to 9.2 months for patients treated with nab-paclitaxel and gemcitabine (HR 0.83 [95% CI 0.70–0.99]; p=0.04).1†

For the first time, a clinical study in the first-line setting for metastatic pancreatic ductal adenocarcinoma demonstrated superior overall survival and progression-free survival for an investigational regimen when compared to standard of care treatment with nab-paclitaxel and gemcitabine” said Zev Wainberg, M.D. Professor of Medicine at UCLA and co-director of the UCLA GI Oncology Program. “These findings are especially meaningful to people living with this aggressive and difficult-to-treat cancer, representing the potential to prolong life with a safety profile consistent with the safety profile of the treatment components.

Very few clinical studies in metastatic pancreatic ductal adenocarcinoma have demonstrated efficacy in the past few decades. Progress has been slow with limited treatment options, hence the NAPOLI 3 results are a meaningful advance for people with previously untreated metastatic pancreatic ductal adenocarcinoma” said Howard Mayer, Executive Vice President and Head of Research and Development for Ipsen. “In totality, the data demonstrate that the investigational Onivyde treatment regimen (NALIRIFOX) provides a survival benefit over nab-paclitaxel plus gemcitabine. We look forward to submitting the data to the FDA.

NAPOLI 3 secondary outcome measures included PFS, objective response rate (ORR), incidence of treatment-emergent adverse events, serious adverse events, and laboratory abnormalities.

  • Trial met its secondary endpoint showing patients treated with NALIRIFOX had a statistically significant improvement in median PFS of 7.4 months versus 5.6 months for nab-paclitaxel and gemcitabine (HR 0.69 [95% CI 0.58–0.83]; p=0.0001).1†
  • ORR was 41.8 percent (36.8%-46.9%; 95% CI) for patients treated with the NALIRIFOX regimen versus 36.2 percent (31.4%-41.2%; 95% CI) for patients treated with nab-paclitaxel and gemcitabine.1
  • The safety profile of NALIRIFOX was manageable and consistent with the profiles of the treatment components. The most common grade 3/4 treatment-emergent adverse events (TEAEs) with more than 10 percent frequency in patients receiving NALIRIFOX versus nab-paclitaxel and gemcitabine included diarrhea (20.3% vs 4.5%), nausea (11.9% vs 2.6%), hypokalemia (15.1% vs 4.0%), anemia (10.5% vs 17.4%) and neutropenia (14.1% vs 24.5%).1

About the NAPOLI 3 trial1

NAPOLI 3 is a randomized, open-label Phase III trial of Onivyde treatment regimen (NALIRIFOX) in patients who have not previously received chemotherapy for metastatic pancreatic ductal adenocarcinoma. NAPOLI 3 enrolled 770 patients across 205 trial site locations in 18 countries. Patients were randomized to receive Onivyde plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen; n=383) twice in a month (days 1 and 15 of 28-day cycle) compared to an injection of nab-paclitaxel and gemcitabine (n=387) administered three times a month (days 1, 8, 15 of a 28-day cycle).

About Onivyde® (irinotecan liposome injection)

Onivyde is a cancer medicine that blocks an enzyme called topoisomerase I, which is involved in copying cell DNA needed to make new cells. By blocking the enzyme, cancer cells are prevented from multiplying and eventually die. In Onivyde, irinotecan is enclosed in tiny fat particles called ‘liposomes,’ which accumulate in the tumor and release slowly over time.

Ipsen is planning to file a supplemental New Drug Application with the U.S. Food and Drug Administration for Onivyde in combination with oxaliplatin plus 5- fluorouracil/leucovorin for the treatment of patients with previously untreated mPDAC following the Fast Track Designation granted in 2020. Onivyde is currently approved in most major markets including the U.S., Europe and Asia in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. Onivyde is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.

Ipsen has exclusive commercialization rights for the current and potential future indications for Onivyde in the U.S. Servier, an independent international pharmaceutical company with an international presence in 150 countries, is responsible for the commercialization of Onivyde outside of the U.S. and Taiwan. PharmaEngine is a commercial stage oncology company headquartered in Taipei and is responsible for the commercialization of Onivyde in Taiwan.

 About Pancreatic Ductal Adenocarcinoma

PDAC is the most common type of cancer that forms in the pancreas with approximately 60,000 people diagnosed in the U.S. each year and nearly 500,000 people globally.2,3 Since there are no specific symptoms in the early stages, PDAC is often detected late and after the disease has spread to other parts of the body (metastatic or stage IV).4 Even in later stages, weight loss, abdominal pain and jaundice are the most common symptoms making PDAC difficult to detect.5 Despite significant advances in cancer treatments since the 1970s, no treatment options for PDAC significantly extend life.4 Currently, fewer than 20 percent of people diagnosed with PDAC survive longer than one year and overall, pancreatic cancer has the lowest five-year survival rate of all cancer types globally and in the U.S.2,3

Please see full U.S. Prescribing Information including Boxed WARNING for Onivyde.

About Ipsen 

Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With Specialty Care sales of €2.6bn in FY 2021, Ipsen sells medicines in over 100 countries. Alongside its external-innovation strategy, the Company’s research and development efforts are focused on its innovative and differentiated technological platforms located in the heart of leading biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen, excluding its Consumer HealthCare business, has around 5,000 colleagues worldwide and is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com

Survival results (OS, PFS) reflect data included in the ASCO GI presentation. These data describe the final analysis after acceptance of the abstract.

References

  1. Wainberg, Z.A et al. NAPOLI-3: A Randomized, Open-label Phase 3 Study of Liposomal Irinotecan + 5-fluorouracil/leucovorin + Oxaliplatin (NALIRIFOX) versus Nab-paclitaxel + Gemcitabine in Treatment-naïve Patients with Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC). Presented at ASCO Gastrointestinal Cancers Symposium, 2023 January 19-21; San Francisco, California.
  2. https://seer.cancer.gov/statfacts/html/pancreas.html
  3. https://www.cancer.net/cancer-types/pancreatic-cancer/statistics
  4. Orth, M., Metzger, P., Gerum, S. et al. Pancreatic ductal adenocarcinoma: biological hallmarks, current status, and future perspectives of combined modality treatment approaches. Radiat Oncol 14, 141 (2019). https://doi.org/10.1186/s13014-019-1345-6
  5. https://www.cancer.org/cancer/pancreatic-cancer/detection-diagnosis-staging/signs-and-symptoms.html

SOURCE: Ipsen

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