RRMM

IASO Bio and Innovent Updated Efficacy and Safety Clinical Data of Equecabtagene Autoleucel（BCMA CAR-T Cell Therapy）for Multiple Myeloma at the 2023 ASCO Annual Meeting

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Monday, June 5, 2023
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The updated data showed long-term follow-up efficacy and safety of the phase 1b/2 study (FUMANBA-1) conducted in 14 centers in China.

Key Points: 
  • The updated data showed long-term follow-up efficacy and safety of the phase 1b/2 study (FUMANBA-1) conducted in 14 centers in China.
  • Among the 103 patients, 68.9% (71/103) had high-risk cytogenetic abnormalities per mSMART 3.0, 12.6%（13/103）had extramedullary multiple myeloma (EMM), and 11.7%（12/103）had received prior CAR-T therapy.
  • Equecabtagene Autoleucel demonstrated a favorable and manageable safety profile: Among the 103 patients, 93.2% (96/103) experienced cytokine release syndrome (CRS).
  • These results are encouraging and entails an opportunity to advance Equecabtagene Autoleucel to earlier lines of treatment to benefit more MM patients."

Janssen Presents Longer-Term Talquetamab Follow-Up Data Showing Overall Response Rates of More Than 70 Percent in Heavily Pretreated Patients with Multiple Myeloma

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Saturday, June 3, 2023
Infection, Maintenance, Dysgeusia, Arm, University, CRS, GPRC5D, University of Arkansas for Medical Sciences, DOR, Aes, Multiple myeloma, Safety, B-cell maturation antigen, OS, Survival, Vanderbilt University Medical Center, Hope, Janssen, Associate, PFS, Assistant, Fungal infection, ASCO, Incidence, QW, American Society of Clinical Oncology, Cytokine release syndrome, Patient, Division, B cell, Janssen Pharmaceuticals, Immunoglobulin G, CR, Johnson & Johnson, Daratumumab, RRMM, Abstract, Society, ORR, BCMA, Pharmaceutical industry, Copper, Vaccine, Medicine, Hyaluronidase

CHICAGO, June 3, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today updated results from the pivotal Phase 1/2 MonumenTAL-1 study of the investigational bispecific antibody talquetamab in the treatment of patients with relapsed or refractory multiple myeloma (RRMM).1 Data from the MonumenTAL-1 study highlight safety and efficacy results (Abstract #8036) and an analysis of infections and parameters of humoral immunity in patients with RRMM treated with talquetamab (Abstract #8020).1,2 These data will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.1,2 Additional data from the Phase 2 TRiMM-2 study, evaluating talquetamab in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), were presented (Abstract #8003) at the meeting.3

Key Points: 
  • CHICAGO, June 3, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today updated results from the pivotal Phase 1/2 MonumenTAL-1 study of the investigational bispecific antibody talquetamab in the treatment of patients with relapsed or refractory multiple myeloma (RRMM).1 Data from the MonumenTAL-1 study highlight safety and efficacy results ( Abstract #8036 ) and an analysis of infections and parameters of humoral immunity in patients with RRMM treated with talquetamab ( Abstract #8020 ).1,2 These data will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.1,2 Additional data from the Phase 2 TRiMM-2 study, evaluating talquetamab in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), were presented ( Abstract #8003 ) at the meeting.3
    Patients in the Phase 1/2 MonumenTAL-1 study (n=339) were treated with subcutaneous (SC) talquetamab at the recommended Phase 2 dose (RP2D) of 0.8 mg/kg biweekly (Q2W) or 0.4 mg/kg weekly (QW) with step-up doses.1 The overall response rate (ORR) to talquetamab was similar across both doses.1 With a median follow-up of 12.7 months, 71.7 percent (104/145) of response-evaluable patients treated with the 0.8 mg/kg Q2W dose achieved a response, 60.7 percent achieved a very good partial response (VGPR) or better, nine percent achieved a complete response (CR), and 29.7 percent achieved a stringent complete response.1 With a median follow-up of 18.8 months, 74.1 percent (106/143) of response-evaluable patients treated with the 0.4 mg/kg QW dose achieved a response, 59.4 percent achieved a VGPR or better, 9.8 percent achieved a CR, and 23.8 percent achieved a stringent CR.1 In a separate cohort of patients treated with prior T-cell redirection therapy, 64.7 percent (33/51) achieved a response, and 54.9 percent achieved a VGPR or better, with a median follow-up of 14.8 months.1
    "The updated results from the MonumenTAL-1 study continue to show the encouraging potential of talquetamab for heavily pretreated patients with multiple myeloma, including those who may have been exposed to prior T-cell redirection therapy," said Carolina Schinke, M.D., Associate Professor of Medicine at the Myeloma Center at the University of Arkansas for Medical Sciences and principal investigator.† "With a high overall response rate among relapsed or refractory patients, the results underscore the efficacy of talquetamab as a novel option for later-line patients who otherwise face a poor prognosis, including patients with high-risk disease."
  • The safety profile was clinically manageable with low rates of Grade 3/4 infections (0.8 mg/kg Q2W dose, 25.5 percent; 0.4 mg/kg QW dose, 21.4 percent) and talquetamab discontinuations (1.5 percent).3 Almost all patients (95.4 percent) received antibacterial, antifungal or antiviral prophylaxis.
  • No new safety signals were observed with longer term follow-up.3 The most common non-hematologic AEs at the 0.8 mg/kg Q2W dose and 0.4 mg/kg QW dose cohorts were CRS (80 percent and 71 percent, respectively; all Grade 1/2), skin-related AEs (84 percent and 71 percent, respectively; Grade 3/4: eight percent and 14 percent, respectively) and nail-related AEs (69 percent and 57 percent, respectively; Grade 3/4: two percent and zero percent, respectively).3
    "The updated findings from MonumenTAL-1 and data from the TRiMM-2 study are exciting, as they demonstrate the continued promise of T-cell redirecting therapies as single agents or in combination with standard-setting treatments in multiple myeloma," said Chris Heuck, M.D., Global Medical Head, Oncology, Janssen Research & Development, LLC.
  • "At Janssen, we recognize that the future of multiple myeloma treatment lies in harnessing the power of combination therapies to target this complex disease, and the talquetamab results seen to date offer new hope to patients in need of additional treatment options."

Janssen Presents First-Ever Results from Dual Bispecific Combination Study Showing 96 Percent Overall Response Rate in Patients with Relapsed or Refractory Multiple Myeloma

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Saturday, June 3, 2023
Neutropenia, Bispecific monoclonal antibody, Antigen, Pi, Therapy, Progression-free survival, CRS, Immunomodulatory imide drug, Aes, Tel Aviv Sourasky Medical Center, EMD, PFS, ASCO, Incidence, American Society of Clinical Oncology, Multiple myeloma, Cytokine release syndrome, Patient, NE, Anemia, Janssen Pharmaceuticals, Annual general meeting, Confidence interval, Johnson & Johnson, RRMM, Teclistamab, Abstract, Thrombocytopenia, Society, ORR, Pharmaceutical industry

"By combining teclistamab and talquetamab, two bispecific antibodies that have demonstrated high efficacy responses in targeting distinct antigens, we evaluated the potential of this unique combination regimen for patients who were resistant or refractory to multiple lines of therapy," said Yael Cohen, M.D., Head of Myeloma Unit, Hematology Institute, Tel-Aviv Sourasky Medical Center, Israel, and principal study investigator.† "The high overall response rates characterized in this study are encouraging and support the continued evaluation of this regimen as a combination therapy."

Key Points: 
  • "By combining teclistamab and talquetamab, two bispecific antibodies that have demonstrated high efficacy responses in targeting distinct antigens, we evaluated the potential of this unique combination regimen for patients who were resistant or refractory to multiple lines of therapy," said Yael Cohen, M.D., Head of Myeloma Unit, Hematology Institute, Tel-Aviv Sourasky Medical Center, Israel, and principal study investigator.† "The high overall response rates characterized in this study are encouraging and support the continued evaluation of this regimen as a combination therapy."
  • The incidence and severity of CRS were consistent with TECVAYLI® and talquetamab monotherapy treatment.1
    "Multiple myeloma becomes progressively more difficult to treat as patients relapse or become refractory to treatment.
  • The RedirecTT-1 data suggest the use of bispecific antibodies with high activity in myeloma, TECVAYLI and talquetamab, may have potential to yield high efficacy responses in this patient population," said Arnob Banerjee, M.D., Ph.D., Global Medical Head, Early Development Oncology, Janssen Research & Development, LLC.
  • "The promising preliminary results observed with the combination, even in patients with extramedullary disease, are highly supportive of continued investigation and reinforce our commitment to evaluate and develop combination regimens built on our deep disease understanding and portfolio of therapeutics."

Pfizer Presents Scientific Advancements from its Leading Oncology Portfolio at ASCO 2023 Annual Meeting

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Thursday, May 25, 2023
Biotechnology, FDA, Other Health, Health, General Health, Pharmaceutical, Oncology, Other Science, Research, Science, Clinical Trials, Protein kinase, Safety, European Medicines Agency, PFE, Encorafenib, MEK, CDK, Acquisition, Patient, Bini, Ageing, NYSE, Priority review, Maintenance, Inc., APLS, AUC, ADP, Toxicity, Binimetinib, EMA, Doxorubicin, Medicine, Hematology, TALA, Learning, Abstract, DNA, HRR, Cancer, BRAF, NSCLC, Shanda, BSC, RRMM, PARP, PBO, Abstract (summary), B-cell maturation antigen, Woman, AVE, Clinical Genitourinary Cancer, SHP2, ASCO, American Society of Clinical Oncology, Annual general meeting, RWE, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Avelumab, Food, BCMA, Breast cancer, Pharmaceutical industry, Vaccine, Seagen, Pfizer

Pfizer Inc. (NYSE: PFE) will present data across its Oncology portfolio and growing pipeline, covering multiple tumor types and novel mechanisms of action at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from June 2 through June 6.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) will present data across its Oncology portfolio and growing pipeline, covering multiple tumor types and novel mechanisms of action at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from June 2 through June 6.
  • With the recently announced proposed acquisition of Seagen*, a leader in antibody-drug conjugate technology, Pfizer is further accelerating its fight against cancer to deliver the next generation of Oncology breakthroughs.
  • “Placing patients at the center of everything we do is a critical component of advancing cutting-edge science and improving outcomes for patients,” said Dany Habr, M.D., Oncology Chief Medical Affairs Officer, Pfizer.
  • **Pfizer has exclusive rights to BRAFTOVI and MEKTOVI in the U.S., Canada, and all countries in the Latin American, African, and Middle Eastern regions.

Gracell Biotechnologies Initiates Investigational Study Evaluating GC012F for Treatment of Refractory Systemic Lupus Erythematosus (SLE)

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Monday, May 15, 2023
Tissue, IIT, CD19, CRS, Bone marrow, Cancer, End organ damage, Quality of life, SLE, Cytokine release syndrome, Patient, Graceling, SAN, B cell, Immune system, Autoimmune disease, Disease, RRMM, Death, IND, ORR, BCMA, Autoantibody, Pharmaceutical industry, Vaccine

SAN DIEGO, Calif., SUZHOU and SHANGHAI, China, May 15, 2023 /PRNewswire/ -- Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer and autoimmune diseases, today announced the initiation of an investigator-initiated trial (IIT) in China of GC012F, the Company's autologous FasTCAR therapeutic candidate dual-targeting B cell maturation antigen (BCMA) and CD19, for the treatment of refractory SLE.

Key Points: 
  • "Our lead candidate GC012F leverages several next-generation CAR-T technologies including CD19/BCMA dual-targeting and the FasTCAR next-day manufacturing.
  • "Patients with refractory SLE have limited options to treat their wide-ranging and often debilitating symptoms.
  • As such, there is urgent, high unmet medical need for more effective – and even curative – therapies, particularly to help manage refractory SLE.
  • [3]
    Gracell's GC012F represents a novel approach entering human study for refractory SLE and pioneers the use of CD19/BCMA dual-targeting CAR-T in autoimmune disease.

Gracell Biotechnologies Reports First Quarter 2023 Unaudited Financial Results, and Provides Corporate Update

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Monday, May 15, 2023
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We are on track to initiate the U.S. IND trial for GC012F in RRMM in the second quarter of 2023,” said Dr. William (Wei) Cao, founder, Chairman and CEO of Gracell.

Key Points: 
  • We are on track to initiate the U.S. IND trial for GC012F in RRMM in the second quarter of 2023,” said Dr. William (Wei) Cao, founder, Chairman and CEO of Gracell.
  • Company-sponsored Phase 1b/2 clinical trial in U.S. (NCT05850234) evaluating GC012F in RRMM on track to initiate in the second quarter of 2023.
  • Company-sponsored Phase 1/2 clinical trial in China evaluating GC012F in RRMM expected to initiate in the third quarter of 2023.
  • On track to commence a China IIT for GC506 in Claudin18.2-positive solid tumors in the second quarter of 2023.

Gracell Biotechnologies to Present Clinical Data on BCMA/CD19 Dual-Targeting FasTCAR-T GC012F in RRMM and B-NHL and Donor-Derived CAR-T GC007g in B-ALL at EHA2023 Congress

Retrieved on: 
Thursday, May 11, 2023
Acute leukemia, CD19, Progression-free survival, CRS, Infection, B-cell maturation antigen, NHL, Cancer, HSCT, Fourth grade, PFS, ASCO, ORR, Congress, CAR, American Society of Clinical Oncology, Patient, B-ALL, Graceling, SAN, Cytokine release syndrome, Annual general meeting, EHA, Leukapheresis, Society, DL2, BCMA, Pharmaceutical industry, Medical device, Vaccine, Paint, RRMM

SAN DIEGO, Calif., and SUZHOU and SHANGHAI, China, May 11, 2023 /PRNewswire/ -- Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that clinical data from three studies in B-NHL, RRMM and B-ALL will be presented at the 2023 European Hematology Association (EHA) Annual Meeting taking place June 8-15 in Frankfurt, Germany, and online. Clinical data from GC012F, the Company's FasTCAR-enabled autologous CAR-T cell therapy dual-targeting B-cell maturation antigen (BCMA) and CD19, in B-NHL (which was selected as an oral presentation) and RRMM, will also be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, and are currently under embargo until Thursday, May 25.

Key Points: 
  • The data showcases a 100% ORR and will be presented on Friday, June 9, 6:00 – 7:00 PM CEST.
  • At day 28 after infusion, 100% patients achieved minimal residual disease negative complete remission with/without incomplete count recovery (MRD- CR/CRi).
  • These data are currently under embargo and will publish on Thursday, May 25, concurrently with ASCO.
  • Details of the GC012F oral presentation in B-NHL are as follows:
    Details of the GC012F poster presentation in RRMM are as follows:
    For more information about the EHA2023 Congress, visit www.ehaweb.org .

ALX Oncology Reports First Quarter 2023 Financial Results and Provides Clinical Development and Operational Highlights

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Thursday, May 11, 2023
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SOUTH SAN FRANCISCO, Calif., May 11, 2023 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today reported financial results for the first quarter ended March 31, 2023 and provided clinical development and operational highlights.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., May 11, 2023 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today reported financial results for the first quarter ended March 31, 2023 and provided clinical development and operational highlights.
  • “In the first quarter of 2023, we continued to make significant progress in advancing our lead program, evorpacept, through new collaborations and clinical trial starts,” said Dr. Jaume Pons, Founder, President and Chief Executive Officer of ALX Oncology.
  • First Quarter 2023 Financial Results:
    Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of March 31, 2023 were $256.2 million.
  • A reconciliation of GAAP to non-GAAP financial results can be found at the end of this press release.

SpringWorks Therapeutics Announces Clinical Data Presentations of Nirogacestat in Combination with BCMA-Directed Therapies at the European Hematology Association 2023 Congress

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Thursday, May 11, 2023
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“These data provide further validation of the mechanistic approach supporting nirogacestat’s ability to enhance the activity of BCMA-directed therapies across modalities.

Key Points: 
  • “These data provide further validation of the mechanistic approach supporting nirogacestat’s ability to enhance the activity of BCMA-directed therapies across modalities.
  • We are pleased that updated data from the GSK-sponsored trial continue to support our thesis that the combination with nirogacestat may further optimize the benefit-risk profile of belamaf monotherapy.
  • “This is the first clinical data set of nirogacestat in combination with a BCMA bispecific agent.
  • “Nirogacestat is being evaluated in combination with three other bispecific agents and we look forward to generating more data with these combinations.”

2seventy bio Announces Additional Data from KarMMa Studies of Abecma (idecabtagene vicleucel) at ASCO 2023 and EHA 2023

Retrieved on: 
Thursday, May 11, 2023
Oncology, Health, General Health, Clinical Trials, Research, Science, Biotechnology, Abstract, Pros, European Hematology Association, Multiple myeloma, TCE, American Society of Clinical Oncology, RCT, Spectroscopy, Trial of the century, ASCO, Congress, CAR, Patient, Risk, Randomized controlled trial, Quality of life (healthcare), EHA, Annual general meeting, MM, RRMM, Society, Pharmaceutical industry, Nursing, Idecabtagene vicleucel

The presentations will highlight clinical and correlative data from the KarMMa-2 and KarMMa-3 clinical trials evaluating Abecma (idecabtagene vicleucel) in patients with relapsed and/or refractory multiple myeloma (RRMM) or newly diagnosed multiple myeloma.

Key Points: 
  • The presentations will highlight clinical and correlative data from the KarMMa-2 and KarMMa-3 clinical trials evaluating Abecma (idecabtagene vicleucel) in patients with relapsed and/or refractory multiple myeloma (RRMM) or newly diagnosed multiple myeloma.
  • “These data highlight the growing body of evidence that further support the value of Abecma across various subgroups of patients with triple-class-exposed relapsed and/or refractory multiple myeloma, who, despite recent advancements, still need more effective treatment options sooner,” said Steve Bernstein, M.D., chief medical officer, 2seventy bio.
  • Additional analysis of outcomes by number of prior lines of therapy from the KarMMa-3 clinical trial showcasing the use of Abecma in patients who received two to four prior lines of therapy.
  • Patient-reported outcomes from the pivotal Phase 3 KarMMa-3 trial in patients with triple-class exposed RRMM treated with Abecma versus standard regimens.