#USA #New York #Multiple Myeloma #ISB 2001 #TRIgnite-1 study

Promising Results from ISB 2001 for Relapsed/Refractory Multiple Myeloma

In an exciting development for the treatment of relapsed or refractory multiple myeloma (RRMM), new findings from the Phase 1 TRIgnite-1 study reinforce the potential of ISB 2001, a first-in-class trispecific antibody. Conducted by Ichnos Glenmark Innovation, these results were shared during a rapid oral presentation at the recent American Society of Clinical Oncology (ASCO) annual meeting.

High Response Rates

The study revealed an overall response rate (ORR) of 74% across nine dose levels among a population of patients who had previously endured an average of six lines of therapy. This impressive ORR is even more noteworthy considering among those patients who had not previously received CAR-T or bispecific therapies, the response rate peaked at 84%. Patients previously treated with T-cell-targeted and BCMA-targeted therapies also reported significant efficacy, with response rates ranging from 71% to 73%.

Implications for Challenging Cases

The remarkable efficacy is particularly vital for patients who had limited options due to previous treatment failures. Professor Hang Quach, M.D., a leading hematologist, emphasized this sentiment, stating that ISB 2001’s performance highlights its exceptional anti-myeloma potency in a challenging patient demographic, including those who've exhausted other therapeutic alternatives. He noted how ISB 2001 might redefine treatment protocols for RRMM by providing new hope for patients with restricted options.

Favorable Safety Profile

In addition to its promising efficacy, ISB 2001 has demonstrated a favorable safety profile, with no dose-limiting toxicities reported during the trial. While cytokine release syndrome (CRS) was observed in 69% of patients, mainly of Grade 1 severity, there were no life-threatening cases. The majority of participants remained on the treatment without significant adverse events, underscoring the potential for ISB 2001 to be a safer option for patients.

Fast Track Designation

Acknowledging its potential, the FDA has granted ISB 2001 Fast Track Designation, which allows for expedited review and development of therapies that address unmet medical needs. With this designation, there is a sense of urgency to continue exploring and expanding upon the findings from the TRIgnite-1 study.

Next Steps

The next phase of the research includes expanding the dose-expansion portion of the study to define the recommended Phase 2 dosing schedule, aiming to confirm the robust responses seen in earlier findings. Dr. Lida Pacaud, Chief Medical Officer at IGI, expressed optimism about advancing ISB 2001 for a broader patient demographic, particularly focusing on heavily pretreated patients.

Study Details

The ongoing study (NCT05862012) assesses the safety and anti-cancer activity of ISB 2001 in patients with RRMM who have previously been treated with various therapies, including immunomodulatory drugs, proteasome inhibitors, and anti-CD38 monoclonal antibodies.

Conclusion

The promising results from the TRIgnite-1 trial illuminate a potential breakthrough in the management of relapsed/refractory multiple myeloma through ISB 2001. As more data unfolds from the upcoming phases of the study, the medical community can maintain hope for effective and safer therapeutic options, particularly for those patients burdened by limited treatment pathways.

ISB 2001 aims not only to enhance the efficacy of treatment modalities for RRMM but also to address critical safety concerns, providing healthcare professionals and patients with renewed optimism in battling this complex disease.