Assertio Announces Results of Rolvedon® (eflapegrastim-xnst) injection Same-Day Dosing Clinical Study

Rhea-AI Summary

Assertio Holdings (NASDAQ: ASRT) announced results from a clinical trial evaluating Rolvedon® (eflapegrastim-xnst) injection when administered on the same day as chemotherapy for early stage breast cancer patients. The open-label, single-arm study, conducted across 13 US sites, demonstrated that Rolvedon, when given 30 minutes post-chemotherapy, achieved 1.8 days to neutrophil count recovery with a 2% febrile neutropenia rate. Notably, no patients required hospitalization for febrile neutropenia, and no new safety concerns were identified. The results were presented at the San Antonio Breast Cancer Symposium.

Positive

• Same-day dosing trial met efficacy endpoints with 1.8 days to neutrophil count recovery
• Low febrile neutropenia rate of 2%
• Zero hospitalizations required for febrile neutropenia
• No new safety signals identified
• Results support convenient same-day dosing potential

Negative

• None.

Insights

Medical Research Analyst

The clinical trial results for Rolvedon's same-day dosing demonstrate significant operational efficiency in treating chemotherapy-induced neutropenia. The key metrics are impressive: 1.8 days to neutrophil count recovery and a mere 2% febrile neutropenia rate, with zero hospitalizations required. This data suggests comparable efficacy to next-day dosing protocols, which could streamline treatment logistics and potentially reduce healthcare costs. The study's robust design across 13 US sites focusing on early-stage breast cancer patients provides credible evidence for treatment protocol modification. The absence of new safety signals further strengthens Rolvedon's clinical profile. This development could enhance treatment adherence and patient convenience, potentially leading to better market adoption and competitive positioning in the neutropenia management space.

Financial Analyst

The positive clinical trial results could strengthen Rolvedon's market position and drive revenue growth for Assertio. Same-day dosing capability provides a significant competitive advantage by reducing hospital visits and associated costs, potentially making Rolvedon more attractive to healthcare providers and payers. For a company with a market cap of 94.5M, this development could expand market share in the lucrative oncology supportive care segment. The streamlined dosing protocol could improve operational efficiency for healthcare providers, potentially leading to increased adoption rates. However, actual commercial impact will depend on successful market penetration and reimbursement policies. The stock could see positive momentum as the market processes these encouraging clinical results.

Same-day dosing results comparable to next day dosing schedules

LAKE FOREST, Ill., Dec. 13, 2024 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients, announced yesterday results of a clinical trial investigating the utility of Rolvedon^® (eflapegrastim-xnst) injection when dosed the same day of chemotherapy for patients with early stage breast cancer (ESBC). The results were presented as part of the San Antonio Breast Cancer Symposium by the American Association of Cancer Research and the University of Texas Health Science Center at San Antonio.

In this open-label, single-arm study (NCT04187898), conducted across 13 sites in the US, individuals received Rolvedon 30 minutes post chemotherapy for ESBC. Rolvedon demonstrated 1.8 days to neutrophil count recovery and a febrile neutropenia rate of 2%. Zero patients required the need for hospitalization and/or intervention for febrile neutropenia. No new safety signals were identified.

"We are pleased with the expected, positive results from the Rolvedon same day dosing trial and the evidence supporting our belief that Rolvedon can make a meaningful difference for patients undergoing chemotherapy. This milestone further underscores our commitment to improving the lives of patients undergoing cancer treatment by providing convenient and effective treatment options," said Brendan O’Grady, CEO of Assertio Therapeutics.

"The excellent safety and efficacy profile of Rolvedon in this trial is very encouraging, providing clinical data indicating that same day dosing outcomes are safe and effective for this unique molecule," said Dr. Howard Franklin, SVP of Medical of Assertio Therapeutics. "Our goal is to enhance patient outcomes and quality of life (QoL), and these results support the potential of Rolvedon to do just that.”

Details of the study and poster presentation can be found at the SABCS website, https://sabcs.org/.

About Assertio

Assertio is a commercial pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients. We have built our commercial portfolio through acquisition or licensing of approved products. Our commercial capabilities include marketing through both a sales force and a non-personal promotion model, market access through payor contracting, and trade and distribution. To learn more about Assertio, visit www.assertiotx.com.

Forward Looking Statements

Statements in this communication that are not historical facts are forward-looking statements that reflect Assertio’s current expectations, assumptions and estimates of future performance and economic conditions. These forward-looking statements are made in reliance on the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements relate to, among other things, future events or the future performance or operations of Assertio, including risks related to the subject matter of this communication and our ability to realize the benefits from our operating model, deliver or execute on our business strategy, including to expand or diversify our asset base and market reach and drive cash flows and growth, successfully integrate new assets, and explore new business development initiatives. All statements other than historical facts may be forward-looking statements and can be identified by words such as “anticipate,” “believe,” “could,” “design,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “imply,” “intend,” “may,” “objective,” “opportunity,” “outlook,” “plan,” “position,” “potential,” “predict,” “project,” “prospective,” “pursue,” “seek,” “should,” “strategy,” “target,” “would,” “will,” “aim” or other similar expressions that convey the uncertainty of future events or outcomes and are used to identify forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors, some of which are beyond the control of Assertio, including the risks described in Assertio’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the U.S. Securities and Exchange Commission (“SEC”) and in other filings Assertio makes with the SEC from time to time.

Investors and potential investors are urged not to place undue reliance on forward-looking statements in this communication, which speak only as of this date. While Assertio may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to update or revise any forward-looking-statements contained in this press release whether as a result of new information or future events, except as may be required by applicable law.

Investor Contact

Matt Kreps, Managing Director
Darrow Associates
M: 214-597-8200
mkreps@darrowir.com

FAQ

What were the key results of Assertio's (ASRT) Rolvedon same-day dosing trial?

The trial showed 1.8 days to neutrophil count recovery, a 2% febrile neutropenia rate, and zero hospitalizations required for febrile neutropenia, with no new safety concerns identified.

How many clinical sites participated in ASRT's Rolvedon study?

The study was conducted across 13 sites in the United States.

What is the timing of Rolvedon administration in the new ASRT study?

Rolvedon was administered 30 minutes post-chemotherapy in early stage breast cancer patients.

Where were Assertio's (ASRT) Rolvedon trial results presented?

The results were presented at the San Antonio Breast Cancer Symposium by the American Association of Cancer Research and the University of Texas Health Science Center.

What is the significance of ASRT's Rolvedon same-day dosing results?

The results support that Rolvedon can be safely and effectively administered on the same day as chemotherapy, potentially offering more convenient treatment options for cancer patients.