June 25, 2024 - 🧬 [nGram] Today’s Oncology Scoop: IMFINZI® Success, Oncoinvent Fast Track, Merck KGaA Update

  1. 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.
    Read more

  2. 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.
    Read more

  3. 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.
    Read more

  4. 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.
    Read more

  5. 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.
    Read more

  6. 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.
    Read more

  7. 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.
    Read more

  8. 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.
    Read more

  9. 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.
    Read more

  10. 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.
    Read more