1stOncology™: Cancer Intelligence Service – Page 213 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

FDA Grants Priority Review for Zepzelca® (lurbinectedin) and atezolizumab (Tecentriq®) combination in Extensive Stage Small Cell Lung Cancer

On June 10, 2025 PharmaMar (MSE:PHM) reported that the U.S Food and Drug Administration (FDA) has granted Priority Review for the supplemental New Drug Application (sNDA) for Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC), following induction therapy with carboplatin, etoposide and atezolizumab (Press release, PharmaMar, JUN 10, 2025, View Sourcefda-grants-priority-review-for-zepzelca-lurbinectedin-and-atezolizumab-tecentriq-combination-in-extensive-stage-small-cell-lung-cancer/" target="_blank" title="View Sourcefda-grants-priority-review-for-zepzelca-lurbinectedin-and-atezolizumab-tecentriq-combination-in-extensive-stage-small-cell-lung-cancer/" rel="nofollow">View Source [SID1234653793]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

The FDA’s Priority Review designation is assigned to applications for drugs that would offer a significant improvement in the safety or effectiveness of the treatment of a serious condition and means FDA’s goal is to take action on the NDA within six months (compared to ten months under standard review). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of October 7, 2025.

Jazz Pharmaceuticals plc (Nasdaq: JAZZ), PharmaMar’s partner in the U.S., submitted the sNDA to the FDA in April based on data from the Phase 3 IMforte trial, which evaluated lurbinectedin plus atezolizumab as a first-line maintenance therapy in patients with ES-SCLC. 483 patients were randomized after completion of 4 cycles of induction therapy with atezolizumab plus carboplatin and etoposide. From the point of randomization, the median OS for the lurbinectedin plus atezolizumab regimen was 13.2 months versus 10.6 months for atezolizumab alone. From the point of randomization, the median PFS by independent assessment was 5.4 months versus 2.1 months, respectively.

Data from the trial served as the basis, also, for the recent submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) by PharmaMar.

PharmaMar informs that Slingshot will host a Key Opinion Leader webcast on June 12th at 17:00h CEST / 11:00 EDT to review the Phase 3 IMforte data for lurbinectedin + atezolizumab in extensive-stage small cell lung cancer, which were presented at ASCO (Free ASCO Whitepaper), as well as the treatment landscape. The webcast will include a discussion panel of Dr. Martin Wermke from TU Dresden and Dr. Nicolas Girard from Institut Curie. The webcast may be accessed from the Investors section at View Source

MacroGenics and Sagard Healthcare Partners Enter into ZYNYZ® Royalty Purchase Agreement

On June 10, 2025 MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported that it has entered into a royalty purchase agreement with Sagard in exchange for a capped royalty interest on future global net sales of ZYNYZ (retifanlimab-dlwr) (Press release, MacroGenics, JUN 10, 2025, View Source [SID1234653792]). ZYNYZ is a PD-1 inhibitor originally developed by MacroGenics and licensed to Incyte pursuant to an exclusive global collaboration and license agreement in October 2017. MacroGenics retains its other economic interests related to ZYNYZ, including future potential development, regulatory and commercial milestones. MacroGenics will also continue to support a portion of global commercial manufacturing needs for ZYNYZ.

Under the terms of the royalty purchase agreement, MacroGenics received a $70 million upfront payment for the sale of its royalty rights on global net sales of ZYNYZ. Following Sagard’s receipt of aggregate royalty payments totaling $140 million (or 2.0x), MacroGenics will resume collecting all future royalties on global net sales.

Additional information regarding the royalty purchase agreement is provided in a Current Report on Form 8-K filed by MacroGenics with the U.S. Securities and Exchange Commission.

As of March 31, 2025, MacroGenics had $154.1 million in cash, cash equivalents and marketable securities. This balance, combined with the $70 million upfront payment from Sagard, projected and anticipated future payments from partners, and anticipated savings from the Company’s ongoing cost-reduction initiatives, is expected to support its cash runway through the first half of 2027. MacroGenics’ expected funding needs reflect planned investments in ongoing clinical and preclinical programs.

About ZYNYZ

ZYNYZ (retifanlimab-dlwr) is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), indicated in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) and as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression or intolerance to platinum-based chemotherapy in the U.S.

ZYNYZ is also indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in the U.S. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

ZYNYZ is marketed by Incyte in the United States.

ZYNYZ is a registered trademark of Incyte.

First Site Activated in EU-Funded DE-ESCALATE Clinical Trial on Advance Metastatic Prostate Cancer

On June 10, 2025 The European Organisation for Research and Treatment of Cancer (EORTC) and Syreon Research Institute reported the official start of DE-ESCALATE, a pragmatic Phase III clinical trial focusing on metastatic prostate cancer (Press release, EORTC, JUN 10, 2025, View Source [SID1234653791]).

DE-ESCALATE is one of three research projects coordinated by EORTC, alongside LEGATO and STREXIT-2, which are also funded by the Horizon Europe Programme.

About metastatic prostate cancer
Prostate cancer is the most frequently occurring cancer in men and the third leading cause of cancer death in men.¹ Despite dramatic improvements in early diagnosis and local treatment, one out of five prostate cancer patients will die from their disease.² While data about the rates of metastasis are limited, about 22% of prostate cancer cases metastasize.3 Advanced metastatic prostate cancer is a heterogeneous disease, for which androgen deprivation therapy combined with an androgen receptor pathway inhibitor (ARPI) is the mainstay of treatment.

Metastatic prostate cancer patients suffer from low quality of life and very burdensome symptoms, including treatment-related side effects.

About DE-ESCALATE
The study will evaluate whether intermittent intensified androgen deprivation treatment (iADT) in metastatic prostate cancer is not inferior to continuous treatment in terms of oncological benefit, while minimizing side effects and resource utilization and improving patient quality of life. It is also designed to detect early if iADT has a negative impact on overall survival compared to continuous therapy.

Up to 1,600 patients are expected to be enrolled in this study across Europe. The clinical trial will be opened in 80 sites in the following 8 countries within the EORTC network (Belgium, Croatia, Czechia, Denmark, Italy, Portugal, Romania, Slovenia) and 30 sites across national networks in Ireland, France, and Spain.4
The study is designed with a strong focus on patient centricity, employing a patient-developed health questionnaire to better assess quality of life improvements.

DE-ESCALATE is managed by a multidisciplinary and multistakeholder consortium involving clinical oncologists, surgeons, health economists, and patient representatives.

To compare the effectiveness of the health interventions tested within the study, Syreon Research Institute will deliver a cost-effectiveness analysis and will also oversee the health policy aspects of the dissemination of the study findings.

The DE-ESCALATE study may lead to improved patient survival and quality of life while also improve health system sustainability.

Azitra, Inc. Announces Presentation at the 2025 BIO International Convention

On June 10, 2025 Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported that the company will present at the BIO International Convention being held June 16-19, 2025, in Boston, Massachusetts (Press release, Azitra, JUN 10, 2025, View Source [SID1234653787]).

The presentation will highlight recent updates and progress in Azitra’s pipeline, including ATR-12, currently in a Phase 1b clinical trial in adult patients with Netherton syndrome and ATR-04, in development for the treatment of moderate to severe EGFRi-associated dermal toxicity in adults.

Details of the presentation are as follows:

Event:

2025 BIO International Convention

Date and Time:

Tuesday, June 17 at 12:00 PM, ET

Location:

Boston Convention & Exhibition Center, Room 154

Presenter:

Travis Whitfill PhD MPH, Cofounder and Chief Operating Officer

During the conference, Dr. Whitfill will conduct one-on-one meetings with registered investors and potential partners, showcasing the company’s business and clinical development strategy, recent corporate achievements, and anticipated milestones.

SNT-5505 awarded US FDA Fast Track designation

On June 10, 2025 Syntara Limited (ASX: SNT), a clinical-stage biotechnology company focused on developing first-in-class treatments in blood cancers and other fibrotic diseases, reported that its lead candidate, SNT-5505, has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of myelofibrosis in patients with an inadequate response to JAK inhibitor therapy (Press release, Syntara, JUN 10, 2025, https://mcusercontent.com/add2e2fa70ec3d0eeaf2a93cc/files/f4d68ff6-99ad-efa0-d705-81378f04fdc1/02955002.pdf [SID1234653779]).

Fast Track designation can be awarded by the FDA after its review of data demonstrating potential benefit, a mechanistic rationale for efficacy and early clinical evidence. With the published and peer reviewed pre-clinical and clinical data, as well as presentations at preeminent hematology meetings, there is a growing body of evidence supporting SNT-5505.

Fast Track designation aims to expedite the review and development of therapies that address serious conditions and unmet medical needs, facilitating earlier drug approval and patient access. Benefits include:

More frequent meetings and communication with the FDA.

Eligibility for Accelerated Approval and Priority Review, subject to meeting relevant criteria.

Potential for Rolling Review in support of a New Drug Application (NDA).

Gary Phillips, Chief Executive Officer of Syntara, stated:

"To have the FDA recognise the quality of the pre-clinical and clinical results generated to date, as well as the therapeutic promise of SNT-5505 through this Fast Track designation, is an outstanding development for Syntara. This supports our efforts to rapidly advance SNT-5505 as a potential new standard of care for patients with myelofibrosis, addressing the noticeable gaps left by existing treatments."