Puma Bio presents Phase II clinical trial data for neratinib at SABCS
Category: #healthcare  By Mateen Dalal  Date: 2019-12-12
  • share
  • Twitter
  • Facebook
  • LinkedIn

Puma Bio presents Phase II clinical trial data for neratinib at SABCS

 

  • Puma Biotechnology will enroll more patients to obtain additional data to support the approval of combination therapy for metastatic breast cancer

Puma Biotechnology, Inc., a biopharmaceutical firm based in California, recently announced that the results for the ongoing Phase II SUMMIT clinical trial of neratinib, a drug developed by Puma, are to be presented at the ongoing 2019 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas. The presentation is being held at a poster session by investigator of the trial, Hans Wildiers, M.D., Ph.D., from University Hospitals Leuven in Belgium.  

The U.S. Food and Drug Administration (FDA) had approved neratinib in July 2017 for the adjuvant treatment of all the adult patients suffering from HER2-positive breast cancer at an early stage which follows adjuvant therapy based on trastuzumab. It is marketed as NERLYNX® (neratinib) tablets in the United States. The European Commission had granted authorization to NERLYNX for the adjuvant treatment of both hormone receptor-positive and early-stage HER2-positive breast cancer in August 2018.

Reportedly, the interim summary of efficacy of breast cohort that had received neratinib, combined with fulvestrant and trastuzumab demonstrated that for 17 evaluable patients, 9 of them (53%) had experienced a complete objective response which were classed as partial responses. The other 10 patients (59%) had an experience of clinical benefit, which is defined as a confirmed finished response or stable response or partial response for a minimum of 24 weeks.

Response at median duration has not been reached while the progression-free survival was observed as 9.8 months. Five patients had continued to get treated during the time of data cut-off.

Prof. Dr. Hans Wildiers commented that the overall combination of neratinib, trastuzumab and fulvestrant therapy exhibits promising clinical activities with responses that are durable in a heavily pretreated metastatic population suffering from breast cancer showing activating HER2 mutations as well as hormone receptor-positive diseases. Wildiers added that the company is looking forward to continuing the enrollment of the cohort of SUMMIT.

 

Source Credit- https://www.pumabiotechnology.com/pr20191211.html

About Author

Mateen Dalal    

Mateen Dalal

Despite working as a professional testing engineer, Mateen Dalal always held a liking for content creation. Following his passion, he now pens down articles for itresearchbrief.com and a couple of similar portals. Mateen is a qualified electronics and telecommunicat...

Read More>>

More News By Mateen Dalal

FDA approves mix-and-match boosters for Pfizer, Moderna, and J&J jabs
FDA approves mix-and-match boosters for Pfizer, Moderna, and J&J jabs
By Mateen Dalal

The FDA (Food and Drug Administration) has reportedly approved booster shots for Johnson & Johns...

Tesla Q4 results uncertain over China factory, supply chain concerns
Tesla Q4 results uncertain over China factory, supply chain concerns
By Mateen Dalal

EV leader Tesla has fared better than others amid the global chip shortage, however, supply-chain is...

Melbourne to ease lengthy COVID-19 lockdown as vaccination rate rises
Melbourne to ease lengthy COVID-19 lockdown as vaccination rate rises
By Mateen Dalal

The Australian city of Melbourne is reportedly gearing up to lift the world’s longest stay-at-...