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Blenrep combinations accepted for review by the US FDA for the treatment of relapsed/refractory multiple myeloma

On November 25, 2024 GSK plc (LSE/NYSE: GSK) reported the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for Blenrep (belantamab mafodotin) in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for the treatment of patients with multiple myeloma who have received at least one prior line of therapy (Press release, GlaxoSmithKline, NOV 25, 2024, View Source [SID1234648608]). The US FDA has assigned a Prescription Drug User Fee Act action date of 23 July 2025.

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Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "Relapsed/refractory multiple myeloma treatment could be transformed by additional, efficacious treatment options with manageable side effects and community-based administration. The evidence from DREAMM-7 and DREAMM-8 supporting our Blenrep combinations submission has been further strengthened by the statistically significant overall survival results from the DREAMM-7 trial. We look forward to working with the FDA on this review."

The US application is based on results from the DREAMM-7 and DREAMM-8 phase III trials, which both met their primary endpoints, showing statistically significant and clinically meaningful improvements in progression-free survival (PFS) for the belantamab mafodotin combinations compared to standard of care triplet combinations in relapsed or refractory multiple myeloma.

Results from both trials also showed clinically meaningful improvements across all other secondary efficacy endpoints, including deeper and more durable responses compared to the respective standard of care combinations. The safety and tolerability profiles of the belantamab mafodotin combinations in the DREAMM-7 and DREAMM-8 trials were broadly consistent with the known profiles of the individual agents.

In a subsequent planned interim analysis, the DREAMM-7 trial also met the key secondary endpoint of overall survival1 (OS), showing a statistically significant and clinically meaningful OS benefit favouring the belantamab mafodotin combination. Efficacy and safety data from this analysis will be presented at the upcoming 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition on 9 December 2024 at 11:15 a.m. PT. A positive trend in OS was observed in DREAMM-8 but was not statistically significant at the time of interim analysis, and follow-up for OS continues.

This is the sixth major regulatory filing acceptance this year for belantamab mafodotin combinations in the treatment of relapsed or refractory multiple myeloma based on the results of the DREAMM-7 and DREAMM-8 trials. In 2024, belantamab mafodotin combinations have been accepted for review in the European Union2, Japan3 (with priority review), United Kingdom, Canada and Switzerland (with priority review for DREAMM-8). In China4, the National Medical Products Administration has granted Breakthrough Therapy Designation for belantamab mafodotin in combination with bortezomib and dexamethasone, as well as priority review for the regulatory application based on the results of DREAMM-7.

About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.5,6 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year.7 Multiple myeloma is a significant and enduring health concern in the US, where more than 35,000 cases are expected to be diagnosed in 2024.6,8 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.9

About DREAMM-7
The DREAMM-7 phase III clinical trial is a multicentre, open-label, randomised trial evaluating the efficacy and safety of belantamab mafodotin in combination with bortezomib plus dexamethasone (BVd) compared to a combination of daratumumab and bortezomib plus dexamethasone (DVd) in patients with relapsed/refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy, with documented disease progression during or after their most recent therapy.

A total of 494 participants were randomised at a 1:1 ratio to receive either BVd or DVd. Belantamab mafodotin was scheduled to be dosed at 2.5mg/kg intravenously every three weeks.

The primary endpoint is PFS as per an independent review committee. The key secondary endpoints include OS, duration of response (DOR), and minimal residual disease (MRD) negativity rate as assessed by next-generation sequencing. Other secondary endpoints include overall response rate (ORR), safety, and patient reported and quality of life outcomes.

Results from DREAMM-7 were first presented10 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series in February 2024, shared in an encore presentation at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, and published in the New England Journal of Medicine.

About DREAMM-8
The DREAMM-8 phase III clinical trial is a multicentre, open-label, randomised trial evaluating the efficacy and safety of belantamab mafodotin in combination with pomalidomide plus dexamethasone (BPd) compared to a combination of bortezomib and pomalidomide plus dexamethasone (PVd) in patients with relapsed/refractory multiple myeloma previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen, and who have documented disease progression during or after their most recent therapy. Compared to the patient population studied in the DREAMM-7 trial, patients in DREAMM-8 were more heavily pre-treated in that all had prior exposure to lenalidomide, 78% were refractory to lenalidomide, 25% had prior daratumumab exposure and of those most were daratumumab refractory.

A total of 302 participants were randomised at a 1:1 ratio to receive either BPd or PVd.

The primary endpoint is PFS as per an independent review committee. The key secondary endpoints include OS and MRD negativity rate as assessed by next-generation sequencing. Other secondary endpoints include ORR, DOR, safety, and patient reported and quality of life outcomes.

Results from DREAMM-8 were first presented11 at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting and published in the New England Journal of Medicine.

About Blenrep
Blenrep is an antibody-drug conjugate comprising a humanised B-cell maturation antigen monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.

Blenrep is approved as monotherapy in Hong Kong. Refer to the local Summary of Product Characteristics for a full list of adverse events and complete important safety information.

Genmab to Present at Citi’s Global Healthcare Conference

On November 25, 2024 Genmab A/S (Nasdaq: GMAB) reported that its Chief Financial Officer Anthony Pagano will take part in a fireside chat at Citi’s 2024 Global Healthcare Conference on December 3, 2024 at 8:30 PM CET/2:30 PM EST (Press release, Genmab, NOV 25, 2024, View Source [SID1234648607]). A webcast of the event will be available on Genmab’s website at
View Source

Exact Sciences Advances Breast Cancer Care with the Oncotype DX® test and Genomic Profiling Research at SABCS 2024

On November 25, 2024 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that it will present 10 abstracts demonstrating the breadth of its Precision Oncology portfolio at the 2024 annual San Antonio Breast Cancer Symposium (SABCS ) from December 10-13 in San Antonio, Texas (Press release, Exact Sciences, NOV 25, 2024, View Source [SID1234648606]).

"Exact Sciences is committed to improving breast cancer care by providing actionable insights that support informed treatment decisions and help achieve the best outcomes for patients across all backgrounds," said Dr. Rick Baehner, Chief Medical Officer, Precision Oncology at Exact Sciences. "For 20 years, the Oncotype DX test has led the way in personalized treatment planning, and the new findings presented at SABCS reinforce its trusted role among clinicians, research institutions, and patients alike. With the addition of our OncoExTra test and our anticipated molecular residual disease monitoring test, we’re equipping clinicians with innovative solutions to support patient needs throughout every stage of cancer care."

In collaboration with leading breast cancer experts and research groups, Exact Sciences will share data highlighting how the Oncotype DX test helps guide effective chemotherapy use in everyday practice and clinical trials. New findings from Japan will show how the test supports decision making in breast cancer treatment and can help manage costs. Additionally, retrospective findings reveal African American women are more likely to have higher Recurrence Score results than non-Hispanic White women, with similar survival outcomes. These insights emphasize how the Oncotype DX test can support more equitable breast cancer care across diverse populations and the need for further research to better understand factors behind racial disparities that currently exist.

Data presentations across Exact Sciences’ Precision Oncology portfolio include:

Title : (Neo)adjuvant nab-PAC weekly vs sb-PAC q2w, followed by EC q2w, in genomically or clinically high-risk HR+/HER- early breast cancer according to ET-response: Final survival results from the WSG ADAPT-HR+/HER2- chemotherapy-trial
Session: Late breaking oral presentation GS3-04. Friday, December 13, 9:00-11:45 AM CST; General Session 3, Hall 1

Title: Correlation between the Oncotype DX Recurrence Score categories and progression-free survival of patients with primary metastatic estrogen-receptor positive and HER2-negative breast cancer
Session: Poster P4-12-01. Thursday, December 12, 5:30-7:00 PM CST; Poster Session 4, Halls 2 and 3

Title: The Oncotype DX test to guide adjuvant chemotherapy treatment decisions for early node-negative HR+/HER2- breast cancer patients in Japan: a cost-effectiveness analysis
Session: Poster P4-11-07. December 12, 5:30-7:00 PM CST; Poster Session 4, Halls 2 and 3

Title: Comparative analysis of the Oncotype DX Breast Recurrence Score assay for neoadjuvant letrozole/abemaciclib versus chemotherapy in Stage II-III, Ki67≥20%, HR+/HER2- breast cancer: insights from the GEICAM/CARABELA trial
Session: Poster P1-09-12. Wednesday, December 11, 12:30-2:00 PM CST; Poster Session 1, Halls 2 and 3

Title: Genomic risk score distribution and outcomes of patients with early-stage breast cancer diagnosed during pregnancy
Session: Poster P1-03-30. Wednesday, December 11, 12:30-2:00 PM CST; Poster Session 1, Halls 2 and 3

Title: Oncotype DX Breast Recurrence Score distribution and prognostic value according to prior pregnancy status in young women with breast cancer
Session: Poster P1-01-23. Wednesday, December 11, 12:30 – 2:00 PM CST; Poster Session 1, Halls 2 and 3

Title: Oncotype DX assay association with breast cancer outcomes in different racial and ethnic groups: a retrospective analysis
Session: Poster P2-07-06. Wednesday, December 11, 5:30-7:00 PM CST; Poster Session 2, Halls 2 and 3

Title: Actionable gene alterations affecting the PI3K/AKT and MAPK signaling pathways in breast cancer
Session: Poster P4-03-25. Thursday, December 12, 5:30-7:00 PM CST; Poster Session 4, Halls 2 and 3

Title: Molecular landscape of breast cancer in pre- and postmenopausal women
Session: Poster P3-03-30. Thursday, December 12, 12:00-2:00 PM CST; Poster Session 3, Section Row 3 & Poster 30

Title: Economic analysis of germline genetic testing to assess for hereditary breast cancer: a systematic review
Session: Poster P4-04-14. Thursday, December 12, 5:30-7:00 PM CST; Poster Session 4, Halls 2 and 3

Boston Scientific Announces Agreement to Acquire Intera Oncology® Inc.

On November 25, 2024 Boston Scientific Corporation (NYSE: BSX) reported it has entered into a definitive agreement to acquire Intera Oncology Inc., a privately held medical device company that provides the Intera 3000 Hepatic Artery Infusion Pump and floxuridine – a chemotherapy drug – both of which are approved by the U.S. Food and Drug Administration (Press release, Boston Scientific, NOV 25, 2024, View Source [SID1234648605]). The Intera 3000 pump is used to administer hepatic artery infusion (HAI) therapy to treat tumors in the liver primarily caused by metastatic colorectal cancer.

There are approximately 1.4 million people in the U.S. living with primary colorectal cancer, and more than 150,000 new cases are diagnosed each year.i For nearly 25% of these patients, the cancer will spread to the liver during their illness.ii In patients who receive HAI therapy to treat their cancer, the Intera 3000 pump is implanted under the skin and a connected catheter is placed in the hepatic artery, which supplies the liver with oxygenated blood. The pump then provides a continuous flow of floxuridine directly into the liver to treat tumors that have metastasized, most commonly from the colon.

"Liver cancer is a leading cause of cancer-related death, and we are committed to providing meaningful solutions to safely and effectively treat various forms of this disease with minimal systemic side effects and improved outcomes for patients," said Peter Pattison, president, Interventional Oncology and Embolization, Boston Scientific. "Interest in HAI therapy has grown in the oncology community given improved techniques, positive clinical results and ongoing trials. We believe this acquisition will enable us to provide a more comprehensive set of solutions to physicians and their patients to treat both primary and metastatic forms of liver cancer."

The Intera 3000 pump is the only constant flow implantable pump for HAI therapy approved in the United States. The safety and effectiveness of the Intera 3000 pump is supported by data from randomized controlled trials demonstrating the clinical benefits of HAI therapy for patients with unresectable colorectal metastases to the liver, both prior to and following resection. Data from these trials have highlighted that HAI therapy significantly improves tumor response, time to progression and overall survival compared to systemic chemotherapy,iii,iv,v and that combining HAI with systemic chemotherapy may lead to extended survival and higher conversion-to-resection rates in both chemotherapy-naïve and previously treated patients.vi,vii Current Phase II and III studies are exploring HAI therapy use in larger patient groups for first-line, second-line and post-surgery adjuvant treatments.

Boston Scientific expects to complete the transaction in the first half of 2025, subject to closing conditions. The transaction is expected to have an immaterial impact on adjusted earnings per share in 2025 and is expected to be more dilutive on a GAAP basis due to acquisition-related net charges and amortization expense. Specific terms of the transaction have not been disclosed.

BioLineRx Reports Third Quarter 2024 Financial Results and Provides Update on Transformation to Drive Shareholder Value

On November 25, 2024 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported its unaudited financial results for the third quarter ended September 30, 2024, and provided updates on strategic actions designed to drive shareholder value (Press release, BioLineRx, NOV 25, 2024, View Source [SID1234648603]).

"The license agreement for APHEXDA that we announced last week was made possible by the tremendous work of our commercial team, who through their hard work proved the significant value that APHEXDA can bring to transplant centers and patients," said Philip Serlin, Chief Executive Officer of BioLineRx. "Our launch progress attracted Ayrmid, who will now, through Gamida Cell, continue to build on the strong commercial foundation that has been laid. We would like to thank our employees for their outstanding contributions to APHEXDA growth and expect this innovative product to reach even more patients with the additional resources from Ayrmid.

"Looking forward, our streamlined and nimble company has a new financial foundation supported by sales royalties and potential milestone payments, which will allow our experienced team to develop important new therapies in rare disease and oncology that address areas with high unmet need. We will also focus on advancing our motixafortide PDAC program through existing collaborations that require de-minimis investment. Through this strategy, we anticipate delivering near- and long-term value for our shareholders," Mr. Serlin concluded.

Corporate Updates

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Executed license agreement with Ayrmid Ltd. to develop and commercialize APHEXDA (motixafortide) in all indications except solid tumors, and across all territories except Asia

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License agreement included a $10 million upfront payment, up to $87 million in potential commercial milestones, and royalties on net sales ranging from 18% to 23%

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BioLineRx will supply motixafortide on a cost-plus basis, for both commercial and development supply

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Certain members of the BioLineRx U.S.-based commercial organization will be transitioned to Ayrmid Pharma Ltd.

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Received $9 million equity investment from certain funds managed by Highbridge Capital Management, LLC, to support BioLineRx’s pipeline expansion

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Operating expense run-rate expected to decrease by more than 70% beginning January 1, 2025 through APHEXDA commercial program transfer and additional headcount reductions

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Company intends to evaluate additional asset opportunities in 2025, with a focus on early-stage clinical programs in oncology or rare diseases that address major areas of unmet need

Financial Updates

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Executed repayment and restructuring agreement with BlackRock EMEA Venture and Growth Lending to repay $16.5 million of approximately $29 million in total debt due; remaining balance will be paid over the next three years at the existing fixed annual interest rate of 9.5 percent

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As of September 30, 2024, the Company had cash, cash equivalents, and short-term bank deposits of $29.2 million

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Following the out-license to Ayrmid, the equity investment from Highbridge and the debt repayment to Blackrock, the Company’s cash, cash equivalents and short-term bank deposits are expected to be approximately $20 million, which management believes will be sufficient to fund operations into 2026, as currently planned

APHEXDA Launch Updates

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Aphexda achieved 10 percent market share milestone of total CXCR4 inhibitor usage in the U.S., which compares APHEXDA to branded MOZOBIL and generic plerixafor in all indications

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Institutions ordering APHEXDA increased by 40 percent in the third quarter

Clinical Portfolio Updates
Motixafortide

Pancreatic Ductal Adenocarcinoma (mPDAC)

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Continued enrollment in the CheMo4METPANC Phase 2b clinical trial collaboration with Columbia University. In addition to Columbia, patient enrollment has begun at Brown University, and three additional sites are anticipated to begin enrollment over the next two quarters. Full enrollment in the randomized trial targeting 108 patients is anticipated in 2027, with a prespecified interim futility analysis planned when 40% of PFS events are observed

Multiple Myeloma

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Collaboration partner Gloria Biosciences’ stem cell mobilization bridging study IND was filed and approved by the Center for Drug Evaluation of the National Medical Products Administration in China. Anticipate initiation of pivotal clinical trial in 1H 2025

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Gloria Biosciences has received regulatory approval to commercialize APHEXDA in the Boao Region of China and Macao, areas in Asia that do not require a bridging study

Sickle Cell Disease (SCD) & Gene Therapy

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Announced oral presentation at ASH (Free ASH Whitepaper) 2024 on initial results from a Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in sickle cell disease (SCD). Sponsored by investigators at Washington University in St. Louis, the findings from this proof-of-concept study suggest motixafortide alone, and in combination with natalizumab, could support the collection of the large number of stem cells required by gene therapies for sickle cell disease within a single apheresis cycle. The presentation will occur at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition taking place December 7-10, 2024, in San Diego, California

Third Quarter 2024 Financial Results

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Total revenue for the three months ended September 30, 2024 was $4.9 million. The Company did not record any revenue during the third quarter of 2023. Revenue for the quarter reflects a portion of the upfront payment from the Gloria Biosciences license, which amounted to $3.2 million, as well as $1.7 million of net revenue from product sales of APHEXDA in the U.S.

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Cost of revenue for the three months ended September 30, 2024 was $0.8 million. The Company did not record any cost of revenue during the third quarter of 2023. Cost of revenue for the quarter primarily reflects the amortization of intangible assets, royalties on net product sales of APHEXDA in the U.S., and cost of goods sold on product sales

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Research and development expenses for the three months ended September 30, 2024 were $2.6 million, compared to $2.7 million for the same period in 2023. The decrease resulted primarily from lower expenses related to the termination of the development of AGI-134 and a decrease in payroll and share-based compensation

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Sales and marketing expenses for the three months ended September 30, 2024 were $5.5 million, compared to $8.1 million for the same period in 2023. The decrease resulted primarily from lower expenses of commercialization activities related to motixafortide. The higher expenses in the corresponding period of 2023 reflect the ramp-up of pre-commercialization activities related to motixafortide

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General and administrative expenses for the three months ended September 30, 2024 were $1.4 million, compared to $1.5 million for the same period in 2023. The decrease resulted primarily from small decreases in a number of G&A expenses

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Net loss for the three months ended September 30, 2024 was $5.8 million, compared to net loss of $16.0 million for the same period in 2023. The net loss for the 2024 period included $0.8 million in non-operating income, compared to non-operating expenses of $3.1 million for the same period in 2023, both primarily related to non-cash revaluation of warrants

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As of September 30, 2024, the Company had cash, cash equivalents, and short-term bank deposits of $29.2 million.

Third Quarter Results Conference Call and Webcast
BioLineRx will report its third quarter 2024 results on November 25, 2024. To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until November 27, 2024; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.