Puma Biotechnology reports positive Neratinib Phase III data

Puma Biotechnology Inc. (PBYI) reported efficacy data for neratinib from the Phase III ExteNET trial. The study involved patients with HER2-positive, hormone receptor-positive (HR+), early-stage breast cancer. The primary endpoint of the trial was invasive disease-free survival. The key secondary endpoint was overall survival. The drug candidate is already approved in the European Union for patients with HR+ breast cancer who initiated treatment within one year of completing an adjuvant trastuzumab-containing regimen.

ExteNET was a multicenter, randomized, double-blind study. It involved 2,840 patients with HER2-positive eBC who were given neratinib after neoadjuvant and/or adjuvant therapy with chemotherapy and trastuzumab. The patients were classified according to their hormone receptor status. The patients were then randomized to be administered either oral neratinib 240 mg/day or placebo for a year.

The data showed that for the HR+ /< 1-year patient population, the absolute 5-year invasive disease-free survival benefit versus placebo was 5.1 percent. The absolute 8-year overall survival benefit was reported to be 2.1 percent. The 5-year cumulative incidence of CNS metastases was at 0.7 percent in the neratinib arm and 2.1 percent in the placebo arm. For the HR+/ <1 year, no pCR subgroup of patients that were at a high risk of disease recurrence, the absolute 5-year iDFS benefit in the neratinib cohort versus placebo was found to be 7.4 percent.

Professor Arlene Chan, Vice Chair Breast Cancer Research Centre - WA, said, This newly published study provides consistent and durable benefits of neratinib in a subset of HER2-positive early stage breast cancer patients who are considered to be at greater risk of relapse: namely patients with HR+ tumors that did not achieve a pCR after neoadjuvant treatment (no pCR). The benefits demonstrated are meaningful in all endpoints evaluated, including iDFS, OS and CNS recurrence, and thus should help guide future clinical decisions.

The data showed that the most common grade 3 adverse events included diarrhea, vomiting and fatigue.

Puma Biotechnology is a biopharmaceutical company. It is mainly engaged in developing and commercializing products in the cancer segment. The company in-licenses the global development and commercialization rights to PB272, the oral neratinib, as well as to PB272 and PB357. PB272 also goes by the name of intravenous neratinib. The oral version of the drug was approved by the FDA for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy in 2017. It is marketed in the United States market under the brand name of NERLYNX in the tablet form.

NERLYNX was given further approval for treating adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting in February 2020. For this indication, the drug had been approved to be used in combination with capecitabine. The drug has been given marketing authorization by the European Commission for specified conditions.

Investment Thesis: The stock has remained steady in the recent past, making it suitable for even conservative long-term portfolios. The latest news and the upcoming catalysts are expected to provide a positive fillip to the stock price.

Y-mAbs Therapeutics Inc. (YMAB) reported that the FDA has delivered a Refusal to File letter with regard to its Biologics License Application for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. The BLA was submitted in August, 2020.

The letter states that the FDA requires further details pertaining certain parts of the Chemistry, Manufacturing and Control module and the Clinical module. However, the regulator has not requested or required any additional non-clinical data. The company stated that it is confident about addressing all points raised by the FDA. It also believes that it can provide the requested additional CMC information.

Y-mAbs plans to submit supplementary data from Study 101. This data includes tumor response data from patients with evaluable disease among the first 24 patients included in the protocol. The company intends to request a Type A meeting with the FDA. It is also looking to work with the FDA to make appropriate amendments to the BLA. Y-mAbs intends to file the reworked BLA before the end of this year.

Y-mAbs is a late-stage clinical biopharmaceutical company. It is mainly focused on developing and commercializing novel, antibody-based therapeutic products for treating cancer. The company has robust development pipeline with two pivotal-stage drug candidates. Out of these, naxitamab is designed to target tumors which express GD2, while omburtamab targets tumors expressing B7-H3.

Despite this setback, the company also reported a positive news, as its leading bispecific antibody program nivatrotamab for the treatment of neuroblastoma was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA.

Investment Thesis: The stock is currently trading close to its highs. Coupled with the latest setback, it is advisable to watch this stock for further development and some meaningful pullback in the price.

Halozyme Therapeutics Inc. (HALO) announced that it has expanded its collaboration and licensing agreement with Argenx. The collaboration deals with the companys Enhanze technology, and the original agreement was signed in February 2019.

The new terms of the agreement provide for Argenx to have an exclusive access to Halozymes Enhanze drug delivery technology for three more targets. The company now can name up to six targets under this collaboration. Dr. Helen Torley, president and chief executive officer of Halozyme, Argenx has made rapid progress in the clinic with efgartigimod utilizing ENHANZE since signing the original agreement, moving to a Phase 2 study initiation for an indication being developed only as SC, within just fourteen months.

So far, Argenx has named two targets for this program. These are human neonatal Fc receptor FcRn and complement component C2. The company can access Enhanze for its FcRn antagonist efgartigimod, its late-stage development for several severe autoimmune diseases.

Halozyme is a biopharmaceutical company. Its Enhanze technology is designed to make various treatments more efficient and time-effective. The technology is based on its proprietary enzyme, rHuPH20. It is mainly used for effectual delivery of injected drugs and fluids with the aim of reducing overall treatment burden. The company has licensed this technology to a number of major biotech and pharma companies, including Alexion (ALXN), Lilly (LLY), Janssen (JNJ) and Pfizer (PFE), among others. Its revenue stream consists of royalties and milestone payments received from such collaborations.

Investment Thesis: The company has strong potential ahead with its robust collaboration framework. However, the stock is currently trading at highs and may see some correction in the near future, providing an opportunity to build a position.

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Puma's Positive Neratinib Data, And Other News: The Good, Bad Ugly Of Biopharma - Seeking Alpha

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