Innovent and IASO Bio Present Updated Long-Term Follow-Up Data for BCMA CAR-T FUCASO® (Equecabtagene Autoleucel) at IMS 2023

Rhea-AI Summary

Innovent Biologics and IASO Bio announce updated long-term follow-up data on BMCA CAR-T therapy for multiple myeloma

Positive

• 82.4% of patients without prior CAR-T achieved sCR/CR
• ORR remains consistently high at 98.9% for patients without prior CAR-T
• 12-month PFS rate improved significantly

Negative

• None.

82.4% of patients without prior CAR-T achieving Complete Response (CR) or better

ROCKVILLE, Md. and SUZHOU, China, Sept. 28, 2023 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, and IASO Bio, a biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, today announced updated long-term follow-up data from two studies for BMCA CAR-T: (1) Results from phase 1b/2 study (FUMANBA-1) in patients with relapsed/refractory multiple myeloma (RRMM) treated with Equecabtagene Autoleucel (Abstract Code P-290) and (2) A model to predict the risk of prolonged thrombocytopenia recovery in relapsed/refractory multiple myeloma patients after anti-BCMA CAR-T Treatment (Abstract Code P-288) at the 2023 International Myeloma Society (IMS) Annual Meeting in Vienna on September 27-30, 2023.

Poster Presentation #1 Overview

Presentation Title: Updated long-term follow-up results of a phase 1b/2 study (FUMANBA-1) in patients with relapsed/refractory multiple myeloma (RRMM) treated with Equecabtagene Autoleucel

Session Title: Treatment of Relapsed/Refractory Multiple Myeloma

Abstract Code: P-290

Session Date and Time: Saturday, September 28, 2023, 12:30 PM - 1:30 PM EEST

Equecabtagene Autoleucel is a chimeric antigen receptor T-cell (CAR-T) therapy featuring fully human B-cell maturation antigen (BCMA)-targeting single-chain fragment variable (scFv) antibody. The updated data showed long-term follow-up efficacy, safety, and persistence of the phase 1b/2 study (FUMANBA-1) conducted in 14 clinical sites in China.

This study enrolled RRMM patients who had received ≥3 prior lines of therapy containing at least one proteasome inhibitor and one immunomodulator and whose disease had progressed after the last line of therapy (CTR20192510, NCT05066646).

As of the data cutoff date of December 31, 2022, a total of 105 participants received Equecabtagene Autoleucel at 1.0×10⁶ CAR-T cells/kg with a median follow-up of 18.07 months (IQR 12.6~21.8) and median prior four lines of therapy (range 3~23). Among the 105 patients, 69.5% (73/105) had high-risk cytogenetic abnormalities per mSMART 3.0, 13.3% (14/105) had extramedullary disease (EMD), and 11.4% (12/105) had received prior BCMA CAR-T therapy.

Efficacy: Among the 103 evaluable patients, the overall response rate (ORR) was 96.1% (99/103), with 91.3% (94/103) of those participants achieving a very good partial response (VGPR) or deeper response, and the stringent complete response/complete response (sCR/CR) rate was 77.7% (80/103). In 91 participants without prior CAR-T therapy, ORR was 98.9% (90/91), 82.4% (75/91) of patients reaching sCR/CR,the 12-month PFS rate was 85.5% (95% CI: 75.75, 91.51).

Among the 103 evaluable participants, the median time to response (mTTR) was 16 days (range 11, 179). The 12-month PFS rate was 80.0% (95% CI: 70.33,86.76). 94.2% (97/103) of patients achieved minimal residual disease (MRD) negativity, and all sCR/CR patients achieved MRD negativity. 80.8% (95% CI: 69.59,88.24) of patients sustained MRD negativity over 12 months and the median duration of MRD negativity was not reached.

Equecabtagene Autoleucel demonstrated favorable efficacy in patients with multiple myeloma (MM) who had received prior CAR-T therapy. Among the 12 MM patients who previously received CAR-T therapy, the ORR was 75.0% (9/12), with 41.7% (5/12) of those patients achieving sCR.

Safety: Among the 105 participants, 93.3% (98/105) experienced cytokine release syndrome (CRS). The majority experienced Grade 1-2 CRS, with only one experiencing ≥ Grade 3 CRS. The median time to CRS onset was 6.0 days (range 1, 13) post-infusion, and the median duration of CRS was 5.0 days (range 2, 30). Only 1.9% (2/105) of the patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS), including one grade 1 and one grade 2 ICANS, with no ≥ grade 3 ICANS. All patients with CRS or ICANS have recovered.

Expansion and Persistence: Equecabtagene Autoleucel in peripheral blood reached the peak at a median of 12 days post-infusion, with a median Cmax of 88001.13 copies/ug DNA. CAR Transgenes were still detectable in 50% (32/64) and 40% (4/10) of patients who completed follow-ups 12-month and 24-months after infusion.

Anti-CAR antibodies developed in only 20 (19.2%) patients after infusion.

Poster Presentation #2 Overview

Presentation Title: A model to predict the risk of prolonged thrombocytopenia recovery in relapsed/refractory multiple myeloma patients after anti-BCMA CAR-T treatment Conference

Session Title: Treatment of Relapsed/Refractory Multiple Myeloma

Abstract Code: P-288

Session Date and Time: September 28, 2023, 12:30 PM - 1:30 PM EEST

Patients with RRMM treated with BCMA CAR-T cell therapy frequently experience hematologic toxicity of persistent thrombocytopenia. This presentation showcases a model that was developed to distinguish between patients at high and low risk for prolonged thrombocytopenia. The model was established after analyzing the baseline clinical characteristics of the participants, PLT, C reaction protein, plasma cells in bone marrow, hemoglobin, and Ig Ferritin—which were ultimately determined to be associated with the recovery of thrombocytopenia. Patients with a model score of 5 or higher post-infusion are at a higher risk for prolonged thrombocytopenia.

The principal investigators Prof. Lugui Qiu，MD，from the Chinese Academy of Medical Science Hematology Hospital, and Prof. Chunrui Li, MD, PhD, from Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, stated, "Multiple myeloma is a hematology malignant disease with a high incidence rate, and relapse and refractory are almost inevitable after current treatments. There's an urgent unmet need for treatments that are well-tolerated and with long persistence. Equecabtagene Autoleucel, a fully human targeted BCMA CAR-T injection, has demonstrated long-lasting efficacy with a durable response. In comparison to the clinical data released at the ASCO 2023 Annual Meeting, the updated study data at IMS shows that among patients without prior CAR-T therapy, ORR remains consistently high at 98.9%. The sCR/CR rate and 12-month PFS rate also significantly improved. This suggests that with longer follow-up periods and larger groups of participants, Equecabtagene Autoleucel continues to show excellent efficacy and safety. These results are encouraging and entail a promising opportunity to reshape RRMM treatment and bring forth new hopes to patients."

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to discover and develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to discovering and developing, manufacturing and commercializing high-quality innovative medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, and ophthalmology diseases to enhance the quality of the patients' lives. Innovent has 10 products in the market, including TYVYT® (Sintilimab Injection), BYVASDA® (Bevacizumab Injection), SULINNO® (Adalimumab Injection), HALPRYZA® (Rituximab Injection), Pemazyre® (Pemigatinib Oral Inhibitor), olverembatinib, Cyramza® (Ramucirumab Injection), Retsevmo® (Selpercatinib Capsules), FUCASO® (Equecabtagene Autoleucel Injection) and SINTBILO® (Tafolecimab Injection). Additionally, we have 1 assets under NMPA NDA review, 7 assets in Phase III or pivotal clinical trials, and 18 more molecules in early clinical stage.

Innovent has also entered into 30 strategic collaborations with Eli Lilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. We strive to work with many collaborators to help advance the biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives.

Note:

TYVYT®, BYVASDA®, SULINNO®, HALPRYZA®, olverembatinib, FUCASO® and SINTBILO® are not approved products in the United States.

TYVYT® (sintilimab injection, Innovent)

BYVASDA® (bevacizumab injection, Innovent)

HALPRYZA® (rituximab injection, Innovent)

SULINNO® (adalimumab injection, Innovent)

Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.

CYRAMZA® (ramucirumab injection, Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Retsevmo® (selpercatinib capsules, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

About IASO Bio

IASO Bio is a biopharmaceutical company engaged in the discovery and development of novel cell therapies and biologics for oncology and autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire drug development process, from early discovery to clinical development, regulatory approval, and commercial production.

The pipeline in the company includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received New Drug Application (NDA) approval from China's National Medical Products Administration (NMPA) and U.S. FDA IND approval for the treatment of RR MM.

Leveraging its strong management team, innovative product pipeline, GMP production, as well as integrated manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China as well as around the world. For more information, please visit http://www.iasobio.com or www.linkedin.com/company/iasobiotherapeutics.

Forward-Looking Statements

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These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

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SOURCE Innovent Biologics