Imfinzi shows significant improvement in survival for muscle-invasive bladder cancer in NIAGARA Phase III trial
- The NIAGARA Phase III trial demonstrated that Imfinzi (durvalumab) combined with chemotherapy significantly improved event-free survival (EFS) and overall survival (OS) in muscle-invasive bladder cancer (MIBC) patients.
- Patients received Imfinzi with neoadjuvant chemotherapy before cystectomy, followed by Imfinzi as adjuvant monotherapy.
- The trial included 1063 patients across 192 centers in 22 countries, with dual primary endpoints of EFS and pathologic complete response.
- Imfinzi was well-tolerated with no new safety concerns, and the addition of Imfinzi did not increase the discontinuation rate due to adverse events.
- These results will be presented at an upcoming medical meeting and shared with global regulatory authorities.
- Next steps include seeking regulatory approvals to bring this new treatment regimen to patients.
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Oncoinvent receives FDA fast track designation for Radspherin as treatment for peritoneal carcinomatosis from ovarian cancer
- Oncoinvent AS announced that the FDA has granted Fast Track designation to Radspherin for treating peritoneal metastases from ovarian cancer.
- The designation is a significant milestone as Oncoinvent prepares to initiate a Phase 2b trial for Radspherin.
- The Phase 2b trial will evaluate the efficacy and safety of Radspherin in patients with peritoneal metastases from ovarian cancer.
- Primary objective: Compare progression-free survival (PFS) between patients receiving Radspherin post-surgery and those undergoing only chemotherapy and surgery.
- Positive interim analysis from Phase 1/2a showed Radspherin was well tolerated with no dose-limiting toxicity at the recommended dose of 7MBq.
- Fast Track designation facilitates development and review, potentially allowing for accelerated approval and priority review.
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Merck KGaA provides update on phase III TrilynX study in locally advanced head and neck cancer
- Merck KGaA has discontinued the Phase III TrilynX study evaluating xevinapant plus chemoradiotherapy (CRT) in patients with unresected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN).
- The decision follows a pre-planned interim analysis indicating the trial would unlikely meet its primary objective of prolonging event-free survival.
- Top-line safety data were overall compatible with the chemo-radio sensitizing properties of xevinapant.
- An in-depth review of the data will be conducted, with results to be shared in a peer-reviewed forum.
- The company also decided to stop the Phase III X-Ray Vision trial (xevinapant plus radiotherapy vs. placebo plus radiotherapy) in patients who underwent resection of locally advanced head and neck cancer.
- Merck KGaA continues to explore new treatment options, including antibody drug conjugates (ADCs) and DNA damage response (DDR) inhibitors, across multiple tumor types.
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SELLAS announces U.S. FDA rare pediatric disease designation granted to SLS009 for the treatment of pediatric acute lymphoblastic leukemia
- SELLAS Life Sciences Group received Rare Pediatric Disease Designation (RPDD) from the FDA for SLS009.
- SLS009 is a highly selective CDK9 inhibitor aimed at treating pediatric acute lymphoblastic leukemia (ALL).
- RPDD provides eligibility for a Priority Review Voucher (PRV) upon marketing approval, which can be sold or transferred.
- Past sales of PRVs have averaged more than $100 million.
- SLS009 has shown a favorable safety profile in clinical trials with no non-hematologic higher-grade toxicities.
- If approved, the PRV could expedite the review process for future marketing applications.
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Sustained Therapeutics announces first patient for cancer trial
- Sustained Therapeutics has enrolled the first patient in the Phase II/III trial of ST-02, targeting Upper Tract Urethral Carcinoma (UTUC).
- UTUC is a rare cancer affecting over 7,000 individuals annually in North America, located in the kidney's collecting system and ureter.
- The trial will enroll approximately 75 patients across 6 sites, with the first patient enrolled at the Vancouver Prostate Centre.
- ST-02 is a sustained release formulation delivering chemotherapy directly to the carcinoma site via a catheter, potentially offering higher efficacy and fewer side effects.
- The company anticipates that ST-02 may receive orphan drug designation, providing incentives like tax credits and market exclusivity.
- Sustained Therapeutics' platform technology aims to develop multiple products, with ST-02 being their second product to reach Phase II trials.
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IMUNON announces database lock for phase 2 OVATION 2 study with IMNN-001 in advanced ovarian cancer
- IMUNON has locked the database for its Phase 2 OVATION 2 Study evaluating IMNN-001 in advanced ovarian cancer.
- The study reached median Overall Survival (OS) and Progression Free Survival (PFS) with a 16-month treatment observation duration.
- Topline results, including hazard ratios, are expected by the end of July 2024.
- OVATION 2 evaluates the safety, efficacy, and biological activity of IMNN-001 combined with neoadjuvant chemotherapy (NACT).
- The study enrolled 110 patients, randomized 1:1, comparing NACT plus IMNN-001 versus standard-of-care NACT.
- The primary efficacy endpoint is PFS, with secondary endpoints including OS, Objective Response Rate, Chemotherapy Response Score, and Surgical Response.
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IDEAYA Biosciences announces first-patient-in for phase 1 clinical trial evaluating IDE397 and Trodelvy combination in MTAP-deletion bladder cancer
- IDEAYA Biosciences has dosed the first patient in a Phase 1 trial for the combination of IDE397 and Trodelvy.
- The trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy in MTAP-deletion bladder cancer.
- MTAP-deletion is present in approximately 26% of bladder cancer patients.
- IDE397 is a MAT2A inhibitor, while Trodelvy is a Trop-2 directed antibody-drug conjugate.
- IDEAYA sponsors the trial, with Gilead providing Trodelvy supply.
- A clinical data update for IDE397 Phase 2 monotherapy in MTAP-deletion bladder and lung cancer is expected in the second half of 2024.
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ExCellThera announces EMA’s acceptance under accelerated assessment of market authorisation application for UM171 cell therapy
- ExCellThera's Market Authorisation Application (MAA) for UM171 Cell Therapy has been accepted under the EMA's accelerated assessment procedure.
- The therapy is intended for adult patients with hematological malignancies who lack a readily available suitable donor.
- UM171 Cell Therapy has received multiple designations, including orphan drug and regenerative medicine advanced therapy (RMAT) from the FDA, and orphan medicinal product and priority medicines (PRIME) from the EMA.
- The therapy has successfully completed Phase 2 trials in patients with high-risk acute leukemias and myelodysplasias.
- A Phase 3 trial is planned for the second half of 2024.
- The use of UM171 Cell Therapy in other patient populations, including multiple myeloma and pediatric patients, is also being explored.
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Panbela Therapeutics announces third independent safety review of Phase 3 ASPIRE clinical trial
- The DSMB recommended the continuation of the ASPIRE trial without modification for the third time.
- The safety database now includes 395 patients, up from 214 in November 2023.
- Lower-than-expected event rate suggests potential for prolonged survival among trial participants.
- Interim survival analysis is expected in early 2025.
- Rapid enrollment positions the company to complete enrollment by Q1 2025, earlier than anticipated.
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Anixa Biosciences treats sixth patient in its ovarian cancer CAR-T clinical trial
- Anixa Biosciences has treated the sixth patient in its Phase 1 clinical trial for ovarian cancer CAR-T therapy.
- This patient is the final one in the second dosage cohort of the trial.
- If no adverse effects are observed, enrollment for the third dosage cohort may begin within the next month.
- The trial targets the follicle-stimulating hormone receptor (FSHR) on ovarian cells, using a novel chimeric endocrine receptor T-cell (CER-T) technology.
- The second cohort received triple the dose of CAR-T cells compared to the first cohort, with no dose-limiting toxicities observed.
- The third dosage cohort will receive a dose ten times higher than the initial dosage.
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