Pfizer Positive 26-Week Data For Biosimilar To Rituximab At ASH

• 26-week data from the ongoing 52-week REFLECTIONS B328-06 study met its primary endpoint, demonstrating comparable safety and efficacy for patients with indolent follicular lymphoma
• The U.S. Food and Drug Administration (FDA) accepted for review, a Biologics License Application (BLA) for PF-05280586 in September 2018

Pfizer, Inc. (NYSE:PFE) announced today at the American Society of Hematology Annual Meeting that the REFLECTIONS B328-06 study, a comparative safety and efficacy study of PF-05280586 versus Rituxan^®/MabThera^® (rituximab-EU)ⁱ, met its primary endpoint of overall response rate (ORR) at Week 26 of the 52-week study.¹

“It is encouraging to see new data supporting a potential rituximab Biosimilar. If approved this may help provide a more cost-effective treatment option and expand access for patients and physicians,” said Dr. Jeff Sharman, medical director, US Oncology Hematology Research. “The data presented today will help us understand the nuances of the medicine without the confounding influence of additional concurrent treatments.”

26-week data from the ongoing 52-week REFLECTIONS B328-06 study (n=394) demonstrated no clinically meaningful differences in efficacy, in terms of ORR at Week 26, between PF-05280586 and MabThera, for the first-line treatment of patients with CD20-positive, low tumor burden, follicular lymphoma (LTB-FL).¹ ORR at Week 26 was 75.5% (PF-05280586) vs 70.7% (rituximab-EU), and was within the pre-specified equivalence margin. ORR is defined as the percentage of patients achieving complete response (CR) or partial response (PR), based on central review. Additionally, estimated rates of one-year progression-free survival were similar across groups (76.4% vs. 81.2% in the PF-05280586 and MabThera groups, respectively).¹ The results also show that PF-05280586 had a similar safety profile to MabThera.¹

“With a patient centered approach and over a decade of experience globally,² Pfizer remains dedicated to developing and delivering high quality biosimilars with similar efficacy and safety profiles to originator medicines that help have a meaningful impact on people living with various conditions including cancer,” said Joe McClellan, vice president, Biosimilars Development at Pfizer. “We have also been a committed global partner to the oncology community for almost 20 years, and the continued growth of our oncology and supportive care presence, through both novel therapies and biosimilars, means we are able to provide patients, physicians and healthcare systems with a wider range of treatment options.”

PF-05280586 has been accepted for review by the FDA, the BsUFA goal date for a decision by the FDA is in second-quarter 2019. Pfizer is also working towards making PF-05280586 available for patients in Europe. Further results on the safety and efficacy from this ongoing 52-week study in LTB-FL are expected to be presented next year.

https://www.biospace.com/article/releases/pfizer-presents-positive-26-week-data-for-pf-05280586-a-potential-biosimilar-to-rituximab-at-the-american-society-of-hematology-annual-meeting/

Janssen’s Cilag in License Agreement for Cancer Immunotherapy Cusatuzumab

Addition of investigational antibody cusatuzumab to robust oncology pipeline reflects Janssen’s commitment to advance innovative therapies for blood cancers where unmet medical needs remain

Cilag GmbH International, an affiliate of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today it has entered into a worldwide collaboration and license agreement with argenx BVBA and argenx SE, to develop and commercialize cusatuzumab (ARGX-110). Cusatuzumab is an investigational therapeutic antibody that targets CD70, an immune checkpoint implicated in numerous cancers, including hematological malignancies. This first-in-class SIMPLE Antibody™ is currently in Phase 1/2 clinical trials to evaluate its safety, tolerability and efficacy in the treatment of acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS). Separately, an equity investment by Johnson & Johnson Innovation – JJDC, Inc. (JJDC) will be made in argenx SE.

Updated data from the ongoing Phase 1/2 clinical study evaluating cusatuzumab in combination with azacytidine in newly diagnosed patients with AML unfit for intensive chemotherapy are being presented during an argenx workshop held in conjunction with the 60^th Annual Meeting of the American Society of Hematology (ASH). The data showed promising anti-leukemia activity in these patients.ⁱ

“We believe CD70 is an important target in the biology of select cancers, and we are eager to accelerate the development of this innovative antibody together with argenx,” said Yusri Elsayed, M.D., MHSc., Ph.D., Vice President, Hematologic Malignancies Disease Area Leader, Janssen Research & Development, LLC. “Phase 1/2 data in acute myeloid leukemia showed the activity of cusatuzumab, and we hope to translate these findings to improve outcomes for patients with myeloid malignancies.”

Under the terms of the agreement, Janssen will jointly develop and globally commercialize cusatuzumab in AML, MDS, and potential future indications, as well as next generation CD70 antibodies. Janssen will make an upfront payment of $300 million USD and additional payments based upon the achievement of certain development, regulatory and sales milestones. Janssen is responsible for commercialization worldwide. In the U.S., argenx has the option to participate in commercialization efforts. Janssen will record worldwide net trade sales. In the U.S., the companies have agreed to share the economics 50/50, and outside the U.S., Janssen will pay double-digit sales royalties to argenx.

“We are pleased to enter into this strategic partnership with argenx and advance a promising antibody for the treatment of AML and other blood cancers where current treatment is limited and effective new interventions are needed for patients,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. “The addition of cusatuzumab deepens our portfolio and adds to our expertise in oncology, and more importantly, it reflects our commitment to combine Janssen’s strengths with those of other outstanding teams to advance science that we believe can transform the treatment of diseases and the lives of patients worldwide.”

The transactions are subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act, and expected to close in the first quarter of 2019.

https://www.biospace.com/article/releases/janssen-affiliate-cilag-gmbh-international-enters-worldwide-collaboration-and-license-agreement-with-argenx-for-cancer-immunotherapy-cusatuzumab/

Euro Meds Agency Extends Application Review of Celltrion antibody biosimilar

 Celltrion, Inc. (KRX:068270) today announced that the European Medicines Agency (EMA) has accepted for review of the Extension Marketing Authorisation Application for ‘Remsima SC’, the subcutaneous (SC) version of Remsima®, the autoimmune disease therapeutic antibody biosimilar of infliximab. An opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) on the Extension Marketing Authorisation Application for Remsima SC is expected in the second half of 2019.

In a bid to secure competitiveness in the TNF-α inhibitor (autoimmune disease therapeutic agent) market through ‘twin-track’ strategy together with the existing intravenous (IV) formulation of Remsima®, Celltrion has developed Remsima SC, the SC version of infliximab. Since May 2016, Celltrion has conducted Phase 1 and Phase 3 clinical trials for the safety, pharmacokinetic and efficacy assessment of Remsima SC.

The development of subcutaneous formulation of Remsima® is one of Celltrion’s marketing strategies to increase TNF-α inhibitor market share. The subcutaneous formulation allows patients to conveniently inject it by themselves according to the administration cycle, unlike intravenous formulation of Remsima that requires patients to visit hospitals for the administration thereof.

Celltrion expects that the potential users will include patients who are satisfied with the therapeutic effects of infliximab and yet want to be administered with the subcutaneous formulation.

“Celltrion is set to promote its Remsima® and Remsima SC as global blockbusters by increasing the Remsima brand share in TNF-α inhibitor market under the strategy of diversifying products with existing IV formulation of Remsima®, already sharing 52% of the Europe’s original medicine market.” says an official from Celltrion. “In addition to these efforts, we will lead the TNF- α inhibitor market with upcoming commercialization of the SC formulation of ‘CT-P17’ as a high-concentration formulation of a proposed adalimumab biosimilar referencing AbbVie’s Humira®, which is undergoing clinical trials.”

https://www.biospace.com/article/releases/european-medicines-agency-accepts-extension-marketing-authorisation-application-for-review-of-celltrion-s-remsima-sc-the-subcutaneous-version-of-remsima-/

Celgene to hold an analyst and investor meeting

Analyst and Investor Meeting where Management will discuss the data presented at the American Society of Hematology (ASH) Annual Meeting will be held in San Diego, CA on December 2 at 11 pm

Webcast: https://edge.media-server.com/m6/p/6xjpd737
https://thefly.com/landingPageNews.php?id=2829226

GBT may benefit from Bluebird potential safety concerns, says Piper Jaffray

Piper Jaffray analyst Danielle Brill notes that while the major catalyst for Global Blood Therapeutics (GBT) remains the regulatory update for voxelotor now expected tomorrow morning, she thinks the stock will also benefit from Bluebird Bio’s (BLUE) setback with its LentiGlobin gene therapy for SCD, namely a patient that developed MDS 3 years post LentiGlobin treatment. Global Blood Therapeutics and Bluebird Bio are two of the major players in the SCD space and Brill thinks patients and docs will prefer the former’s voxelotor “now more than ever,” given the potential safety liabilities of gene therapy. The analyst reiterates an Overweight rating and $80 price target on Global Blood’s shares.

https://thefly.com/landingPageNews.php?id=2830838

Celgene announces results of Phase 3 AUGMENT lymphoma study at ASH

Celgene announced results of the phase 3 AUGMENT study, which showed that REVLIMID in combination with rituximab demonstrated superior progression-free survival in patients with relapsed/refractory indolent lymphoma compared to patients who received rituximab plus placebo. The data were at the 60th American Society of Hematology Annual Meeting and Exposition.The phase 3 randomized, double-blind, international clinical study evaluated the efficacy and safety of the investigational combination of R2 versus rituximab plus placebo in patients with relapsed/refractory follicular and marginal zone lymphoma. In the study, the R2 arm demonstrated a highly statistically significant improvement in the primary endpoint of progression-free survival, evaluated by an independent review committee, versus the R-placebo arm. The median PFS was 39.4 months for patients treated with R2 and 14.1 months for those treated with R-placebo. Overall survival, a secondary endpoint, showed a positive trend for improvement in the R2 arm vs. the control arm. Two-year OS rate was 93% for patients receiving R2 and 87% for those receiving R-placebo. Overall response rate, another secondary endpoint, was 78% in the R2 arm vs. 53% in the R-placebo arm, according to the independent review committee. Duration of response was significantly improved for R2 vs. R-placebo with median DoR of 37 vs. 22 months, respectively. The most frequent adverse event in the R2 arm was neutropenia, vs. 22% in the R-placebo arm. No unexpected safety findings were observed in the AUGMENT trial. REVLIMID alone or in combination with other agents is not approved for use in follicular lymphoma or marginal zone lymphoma in any geography.

https://thefly.com/landingPageNews.php?id=2830835

‘Solid’ early single agent activity for ImmunoGen ‘632, says Piper Jaffray

Piper Jaffray analyst Joseph Catanzaro notes that ImmunoGen presented updates from the Phase I trials of both IMGN632 and IMGN779in r/r AML and BPDCN at ASH this weekend. While the aanalyst acknowledges that some may be disappointed with the slight dip in CR/CRi rate for ‘632 and the lack of dose response, he finds the clear anti-leukemic activity at the lower, more tolerable doses notable and sees this as a positive first full look for this program. ‘779 still looks to be struggling to find an active dose, Catanzarro contends, adding that he is unsure whether higher doses will elicit enough of an increase in activity without increased toxicity that would warrant further monotherapy development. He reiterates an Overweight rating and $14 price target on the shares.

https://thefly.com/landingPageNews.php?id=2830819