Athenex Presents Data on Oral Docetaxel and Oral Paclitaxel at ASCO2021 Virtual Scientific Program

Rhea-AI Summary

Athenex, Inc. (NASDAQ: ATNX) presented significant findings at ASCO2021, showcasing the efficacy of its oral cancer therapies. Data from a phase I study indicated that oral docetaxel achieved pharmacokinetic exposure comparable to IV docetaxel, with an average bioavailability of 15.9%. Additionally, an update from the phase III oral paclitaxel study revealed a notable overall response rate of 35.8% compared to 23.4% for IV paclitaxel, indicating superior effectiveness across tumor subtypes. These results may influence future treatment strategies in oncology.

Positive

• Oral docetaxel showed pharmacokinetic exposure comparable to IV docetaxel with 15.9% bioavailability.
• Oral paclitaxel demonstrated a superior overall response rate of 35.8% versus 23.4% for IV paclitaxel.

Negative

• None.

• Data from oral docetaxel phase I pharmacokinetic study shows oral administration can achieve exposure comparable to IV docetaxel
  
• Post-hoc subgroup efficacy analysis based on updated tumor subtypes in the oral paclitaxel phase III study demonstrated an improved response rate with oral paclitaxel plus encequidar across tumor subgroups

BUFFALO, N.Y., June 04, 2021 (GLOBE NEWSWIRE) -- Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, announced today that the Company presented data from a phase I pharmacokinetic study of oral docetaxel plus encequidar (“oral docetaxel”) and updated data from the phase III study of oral paclitaxel plus encequidar (“oral paclitaxel”) illustrating tumor responses by molecular subtype. The data are being presented in two posters at the American Society for Clinical Oncology 2021 (ASCO2021) Virtual Scientific Program, being held from June 4^th to June 8^th, 2021.

An open label, pharmacokinetic study to determine the bioavailability, safety and tolerability of single dose oral docetaxel (Oradoxel) in metastatic prostate cancer mPC patients treated with IV docetaxel
Abstract 5050; Poster session: Genitourinary Cancer – Prostate, Testicular, and Penile

Data were presented from the open-label, two-way crossover phase I pharmacokinetic study of oral docetaxel vs IV docetaxel, which demonstrated the drug was well tolerated with no dose limiting toxicities, or drug-related serious adverse events. The mean absolute bioavailability was 15.9% (range 8% to 25%) with PK exposure becoming non-linear at 300 mg/m². Based on these results and the results of other related studies, oral docetaxel 300 mg/m² as divided doses is being further evaluated.

Confirmed Tumor Response by Molecular Subtype in Patients with Metastatic Breast Cancer (MBC): Sub analysis From a Phase 3 Clinical Study Comparing Oral Paclitaxel and Encequidar to IV Paclitaxel
Abstract 1073; Poster session: Breast Cancer – Metastatic

Updated data were presented from the phase III trial of oral paclitaxel, specifically tumor response rates by receptor subtype. Athenex presented the results of a post-hoc subgroup efficacy analysis based on additional tumor subtype data. Overall response rate in the intent-to-treat (ITT) population demonstrated that oral paclitaxel was superior to IV paclitaxel with confirmed response rates of 35.8% versus 23.4%, respectively (p=0.0107). Response based on tumor subtypes is listed in the table below.

	N (%)	Oral Paclitaxel plus Encequidar ORR (n=265)	IV Paclitaxel ORR (N=137)	Response Rate Difference
Total (ITT)	402	35.8% (95/265)	23.4% (32/137)	12.4%
HR+/HER2-	244	28.0% (47/168)	19.7% (15/76)	8.3%
HR-/HER2-	57	44.8% (13/29)	21.4% (6/28)	23.4%
HER2+	70	49.0% (25/51)	47.4% (9/19)	1.6%
HER2 Unknown	31	58.8% (10/17)	14.3% (2/14)	44.5%

About Athenex, Inc.

Founded in 2003, Athenex, Inc. is a global clinical stage biopharmaceutical company dedicated to becoming a leader in the discovery, development, and commercialization of next generation drugs for the treatment of cancer. Athenex is organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform, and a Global Supply Chain Platform. The Company’s current clinical pipeline is derived from four different platform technologies: (1) Orascovery, based on P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) Cell therapy, and (4) Arginine deprivation therapy. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active and tolerable treatments. For more information, please visit www.athenex.com.

Forward-Looking Statements

Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. These forward-looking statements are typically identified by terms such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: the development stage of our primary clinical candidates and related risks involved in drug development, clinical trials, regulation, uncertainties around regulatory reviews and approvals; our ability to scale our manufacturing and commercial supply operations for current and future approved products, and ability to commercialize our products, once approved; ability to successfully demonstrate the safety and efficacy of its drug candidates and gain approval of its drug candidates on a timely basis, if at all; the preclinical and clinical results for Athenex’s drug candidates, which may not support further development of such drug candidates; risks related to counterparty performance, including our reliance on third parties for success in certain areas of Athenex’s business; our history of operating losses and our need and ability to raise additional capital; uncertainties around our ability to meet funding conditions under our financing agreements and access to capital thereunder; risks and uncertainties inherent in litigation, including purported stockholder class actions; risks and uncertainties related to the COVID-19 pandemic and its potential impact on our operations, supply chain, cash flow and financial condition; competition; intellectual property risks; uncertainties around our ability to successfully integrate acquired and merged businesses in a timely and cost-effective manner and to achieve synergies; risks relating to doing business internationally and in China; the risk of development, operational delays, production slowdowns or stoppages or other interruptions at our manufacturing facilities; and the other risk factors set forth from time to time in our SEC filings, copies of which are available for free in the Investor Relations section of our website at http://ir.athenex.com/phoenix.zhtml?c=254495&p=irol-sec or upon request from our Investor Relations Department. All information provided in this release is as of the date hereof and we assume no obligation and do not intend to update these forward-looking statements, except as required by law.

Athenex Contacts

Investors:

Daniel Lang, MD
Athenex, Inc.
Email: danlang@athenex.com

Tim McCarthy
LifeSci Advisors, LLC
Email: tim@lifesciadvisors.com 

FAQ

What were the findings of the phase I pharmacokinetic study for oral docetaxel presented by Athenex?

The phase I study demonstrated that oral docetaxel achieved pharmacokinetic exposure comparable to IV docetaxel, with an average bioavailability of 15.9%.

What did the phase III study reveal about oral paclitaxel's effectiveness?

The phase III study indicated that oral paclitaxel had an overall response rate of 35.8%, which was significantly higher than the 23.4% response rate for IV paclitaxel.

When and where were these findings presented by Athenex?

Athenex presented these findings at the American Society for Clinical Oncology 2021 (ASCO2021) Virtual Scientific Program from June 4 to June 8, 2021.

What is the significance of the findings for Athenex's stock (ATNX)?

The positive results regarding the efficacy of oral docetaxel and oral paclitaxel could enhance investor confidence in ATNX, potentially impacting its stock performance positively.