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Halozyme Announces FDA Approval of Bristol Myers Squibb’s Opdivo Qvantig™ with ENHANZE® for Subcutaneous Use in Most Previously Approved Adult Solid Tumor Opdivo® (nivolumab) Indications

On December 30, 2024 Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) reported that Bristol Myers Squibb received U.S. Food and Drug Administration (FDA) approval for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) co-formulated with Halozyme’s ENHANZE drug delivery technology for subcutaneous use in most previously approved adult, solid tumor intravenous (IV) Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib (Press release, Halozyme, DEC 30, 2024, View Source [SID1234649364]). Opdivo Qvantig is the first and only subcutaneously administered PD-1 inhibitor.

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The subcutaneous administration of Opdivo Qvantig is faster, with a three- to five-minute administration time compared to 30 minutes for IV Opdivo.* Subcutaneous administration may offer flexibility to receive treatment where it is best for patients and their providers, may reduce steps required for preparation and time needed for administration.

"We are pleased Opdivo Qvantig, which is co-formulated with our ENHANZE drug delivery technology, is now FDA-approved as the first and only subcutaneously administered PD-1 inhibitor in the U.S.," said Dr. Helen Torley, president and chief executive officer of Halozyme. "This approval represents our ninth co-formulated product and is yet another example of how Halozyme’s innovative ENHANZE technology is enabling greater flexibility and optionality for patients."

The FDA approval is based on the results from the Phase 3 randomized, open-label CheckMate-67T trial, which was a noninferiority trial evaluating Opdivo Qvantig co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20), compared to intravenous Opdivo, in adult patients with advanced or metastatic clear cell renal cell carcinoma who received prior systemic therapy. In the trial, noninferiority was demonstrated for the co-primary endpoints of time-averaged concentration over 28 days (Cavgd28) and minimum concentration at steady state (Cminss) of Opdivo Qvantig vs. IV Opdivo. The geometric mean ratio (GMR) for Cavgd28 was 2.10 (90% CI: 2.00-2.20) and the GMR for Cminss was 1.77 (90% CI: 1.63-1.93). As a key powered secondary endpoint, the overall response rate (ORR) in the Opdivo Qvantig arm (n=248) was 24% (95% CI: 19-30) compared with 18% (95% CI: 14-24) in the IV Opdivo arm (n=247) showing that Opdivo Qvantig has similar efficacy compared to IV Opdivo as assessed by Blinded Independent Central Review (BICR).

Select Safety Profile from CheckMate-67T

Serious adverse reactions occurred in 28% of patients receiving Opdivo Qvantig. The most frequent serious adverse reactions reported in >1% of patients who received Opdivo Qvantig were pleural effusion (1.6%), pneumonitis (1.6%), hyperglycemia (1.2%), hyperkalemia (1.2%), hemorrhage (1.2%) and diarrhea (1.2%). The most common adverse reactions (reported in ≥10% of patients) were fatigue (20%), musculoskeletal pain (31%), pruritus (16%), rash (15%), arthralgia (12%) and cough (11%). Fatal adverse reactions occurred in 3 (1.2%) patients who received Opdivo Qvantig; these included myocarditis, myositis, and colitis complications. Study therapy was discontinued in 10% of patients due to adverse reactions. The safety profile of Opdivo Qvantig was comparable with the safety profile of IV Opdivo.

ADC Therapeutics Announces Completion of Enrollment of Phase 3 Confirmatory Clinical Trial of ZYNLONTA® in Combination with Rituximab in 2L+ Diffuse Large B-Cell Lymphoma

On December 30, 2024 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported the completion of enrollment in LOTIS-5, the Phase 3 confirmatory trial evaluating ZYNLONTA (loncastuximab tesirine-lpyl) in combination with rituximab (Lonca-R) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) (Press release, ADC Therapeutics, DEC 30, 2024, View Source [SID1234649363]). ZYNLONTA previously received accelerated approval for the treatment of r/r DLBCL after two or more lines of systemic therapy from the FDA in 2021.

"This milestone for LOTIS-5 brings us a step closer to providing a potential combination treatment in the 2L+ DLBCL setting that we believe will offer competitive efficacy with favorable safety and a convenient dosing schedule, well-suited for use in patients across care settings," said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. "We anticipate sharing topline results of the primary endpoint analysis by the end of 2025 once the pre-specified number of events is reached and potentially submitting our supplemental BLA to the U.S. Food and Drug Administration (FDA) in the first quarter of 2026."

The randomized, open‐label, two‐part, two‐arm, multicenter study is designed to confirm accelerated approval and may support potential label expansion into 2L+ in combination with rituximab. Twenty patients were enrolled in part 1 of a non-randomized safety run‐in. As previously reported, the results showed an overall response rate (ORR) by central review of 80% (16/20) with a complete response (CR) rate of 50% (10/20) and no new safety signals.

In part 2, patients with 2L+ DLBCL are randomized 1:1 to receive fixed-dose ZYNLONTA with rituximab or rituximab‐gemcitabine‐oxaliplatin (R‐GemOx). The primary endpoint of LOTIS-5 is progression-free survival with secondary endpoints of overall survival, ORR, CR rate and duration of response as well as frequency and severity of adverse events. Topline results of the primary endpoint analysis are anticipated by the end of 2025 once the required number of pre-specified events is reached followed by regulatory submission to the FDA in Q1 2026 and potential approval in late 2026.

For more information about LOTIS-5, please visit View Source (identifier NCT04384484).

About ZYNLONTA (loncastuximab tesirine-lpyl)
ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

Bridge Biotherapeutics to Present at the 43rd Annual J.P. Morgan Healthcare Conference

On December 30, 2024 Bridge Biotherapeutics (KQ288330), a clinical-stage biotech company based in South Korea developing novel drugs for fibrosis and cancer, reported that James Jungkue Lee, Founder and CEO of Bridge Biotherapeutics, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2025 (Press release, Bridge Biotherapeutics, DEC 30, 2024, View Source [SID1234649362]).

Location: Georgian Room (Mezzanine Level) at The Westin St. Francis

Date: Thursday, January 16, 2025

Time: 9:45-10:25 a.m. PST

During the conference, Bridge Biotherapeutics will also meet with potential partners and investors as the Company is looking for Business Development opportunities for further development of BBT-877, a novel drug candidate for idiopathic pulmonary fibrosis (IPF). Top-line results from the Phase 2 study of BBT-877 are expected in April 2025.

CARsgen Announces Positive Topline Results from China GC/GEJ Pivotal Phase II Clinical Trial of Claudin18.2 CAR-T (Satri-cel)

On December 30, 2024 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported the positive results from the pivotal Phase II clinical trial CT041-ST-01(NCT04581473) (Press release, Carsgen Therapeutics, DEC 30, 2024, View Source [SID1234649361]). This study is an open-label, multicenter clinical trial evaluating the safety and efficacy of satricabtagene autoleucel ("satri-cel", CT041) (an autologous CAR T-cell product candidate against Claudin18.2) in subjects with Claudin18.2 expression-positive, advanced gastric/gastroesophageal junction cancers that have failed at least 2 prior lines therapy. Patients were 2:1 randomly assigned to receive treatment of satricabtagene autoleucel infusion or treatment of physician’s choice (including paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab). The primary endpoint of the trial is progression-free survival (PFS) assessed by the Independent Review Committee (IRC). The study met its primary endpoint of a statistically significant improvement in PFS assessed by IRC for patients treated with satri-cel infusion as compared to treatment of physician’s choice (paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab). Previous data demonstrates that the safety profile of satricabtagene autoleucel was manageable.

"We are thrilled to see that satri-cel has achieved positive results in the pivotal Phase II clinical trial in China. The study demonstrates that satri-cel provides significant benefits to gastric cancer patients who have failed at least two prior lines of therapy. This represents a groundbreaking milestone for the field of CAR-T therapies against solid tumors. We anticipate submitting an NDA to the NMPA in the first half of 2025 and look forward to satri-cel becoming the world’s first CAR-T product for solid tumors, bringing hope to more patients as soon as possible. Additionally, we will continue to explore the potential of satri-cel in adjuvant therapy for gastric and pancreatic cancers, aiming to deliver even greater benefits to patients," said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics.

About Satri-cel

Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. Satri-cel targets the treatment of Claudin18.2 positive solid tumors with a primary focus on gastric cancer/gastroesophageal junction cancer (GC/GEJ) and pancreatic cancer (PC). Ongoing trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced gastric/gastroesophageal junction cancer in China (CT041-ST-01, NCT04581473), a Phase I clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595). Satri-cel was granted Regenerative Medicine Advanced Therapy (RMAT) designation by U.S. FDA for the treatment of advanced GC/GEJ with Claudin18.2-positive tumors in January 2022. Satri-cel received Orphan Drug designation from the U.S. FDA in 2020 for the treatment of GC/GEJ.

Duality Biologics Announces B7H4 ADC Milestone Achievement and License Exercise by BeiGene

On December 30, 2024 Duality Biologics ("DualityBio") reported that, BeiGene. Ltd. has exercised its exclusive option for the B7H4 antibody-drug conjugate (ADC) DB1312/BG-C9074 from DualityBio, securing global development, manufacturing, and commercialization rights for the investigational product (Press release, DualityBio, DEC 30, 2024, View Source [SID1234649360]). In 2024, DualityBio received an option exercise fee and a milestone payment based on the Phase I dose-escalation advancement.

In July 2023, DualityBio announced an agreement for BeiGene to acquire its exclusive option for a global clinical and commercial license to an investigational, preclinical ADC therapy for patients with select solid tumors. Under the terms of the agreement, DualityBio received an upfront payment, and is eligible for a payment contingent upon BeiGene exercising its option and additional payments based upon the achievement of certain development, regulatory, and commercial milestones, totaling up to $1.3 billion, in addition to tiered royalties.