New early breast cancer drug to be made available in Australia, New Zealand and Southeast Asia following license deal.
A new breast cancer drug shown to reduce the risk of cancer recurrence will soon be made available in Australia, New Zealand, and throughout Southeast Asia, following a license deal between Specialised Therapeutics Asia (ST Asia) and U.S. biopharmaceutical company Puma Biotechnology, Inc.
Under the terms of the exclusive arrangement, ST Asia will market the drug Nerlynx (neratinib) throughout the Asia-Pacific, beginning with Australia, Singapore, Malaysia, and Brunei.
It will be available to women with early-stage, HER2+ breast cancer following standard of care adjuvant chemotherapy and 12 months of trastuzumab-based therapy.
Commercial terms of the agreement are not being disclosed, but Puma will receive an upfront payment as well as milestones and other payments on Nerlynx sales in all ST Asia regions.
Nerlynx is the first treatment to be FDA approved for extended adjuvant therapy in early-stage HER2+ breast cancer following adjuvant trastuzumab-based therapy.
Results from a double blind, placebo-controlled, randomized Phase 3 study showed that Nerlynx reduces the risk of invasive disease recurrence or death by 27 percent compared to placebo after a median follow up of 5.2 years. The 5-year invasive disease-free survival (iDFS) rate for the Nerlynx arm was 90.2 percent compared to 87.7 percent in the placebo arm (p=0.008).1
For the pre-defined subgroup of patients with hormone receptor positive disease, approximately 57 percent of the overall study population, the results of the trial demonstrated that at 5 years, treatment with neratinib resulted in a 40 percent reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.60, p = 0.002 ).3 In this sub-group, the 5-year iDFS rate for the neratinib arm was 91.2 percent compared to 86.8 percent in the placebo arm.1
The safety results showed the most frequently observed adverse event for the Nerlynx-treated patients was diarrhea, with approximately 40 percent of the Nerlynx-treated patients experiencing grade 3 or higher diarrhea (1 patient (<1%) had grade 4 diarrhea). Patients who received Nerlynx in this trial did not receive any prophylaxis with anti-diarrheal agents.1,2
Principal trial investigator, Professor Arlene Chan, said the availability of Nerlynx in Australia and other regions was an important step forward in further reducing recurrence in HER2+ early breast cancer.
“This is a drug that provides a potential cure for some women who may otherwise have had a recurrence,” she said. “Despite the clear proven benefit of standard of care chemotherapy and trastuzumab therapy, one in four women diagnosed with early-stage HER2+ breast cancer can still have a relapse within five years. This drug will now prevent some of those women from experiencing that recurrence. My hope and expectation is that with longer follow up, not only will recurrence rates be reduced, but they will show that the use of Nerlynx will improve overall survival.”
ST Asia Chief Executive Officer Carlo Montagner said Nerlynx was a valuable inclusion to the company’s expanding oncology portfolio.
“We are thrilled to be able to provide this therapy to women in our regions, working in collaboration with our new international partner, Puma Biotechnology,” he said. “We plan to expedite access to this important medicine, with a Special Access Program to open in Australia in Q1 2018. This will provide early subsidized access for appropriate patients. In tandem, we will file for TGA registration and seek regulatory approval to market in other regions, including Singapore, Brunei, Malaysia, and New Zealand.”
President and CEO of Puma Biotechnology Alan H. Auerbach said this license agreement demonstrates the commitment to bringing Nerlynx to patients around the world. “We are confident this new partnership with ST Asia will ensure all appropriate patients in the region can access this new medicine at the earliest opportunity.”
Nerlynx is an oral medication taken after chemotherapy and after 12 months of treatment with a trastuzumab-based therapy, which is the global standard of care.
1 Martin M et. al. Lancet Oncol. 2017 Nov 13: S1470-2045 [Epub ahead of print]
2 Chan A et.al. Lancet Oncol. 2016;17(3):367-77
3 Martin M. et. Al. ESMO 2017. Oral Presentation #1490
(Source: Puma Biotechnology, Inc.)