Teclistamab is a bispecific antibody that targets BCMA [B-cell maturation agent] and CD3. BCMA is highly expressed on myeloma cells and has limited expression on normal tissue, making it an ideal target for anti-myeloma strategies Read More- https://www.delveinsight.com/asco-conference/article/teclistamab-asco?utm_source=Promotion&utm_medium=ASCO&utm_campaign=ConferenceCoverage

1. ASCO 2022 Conference July 19, 2022
Teclistamab, a soon-to-be-approved bispecific
antibody, demonstrates its promise in Multiple
Myeloma during ASCO 2022
ASCO 2022: Teclistamab for Multiple Myeloma
Latest teclistamab findings presented at the ASCO 2022 Annual
Meeting demonstrate a profound and long-lasting response (Abstract
# 8007, 8013, and 8032)
Mechanism of Action: Bispecific IgG4 antibody that binds BCMA and CD3
to redirect T-cells to multiple myeloma cells
Teclistamab is a bispecific antibody that targets BCMA [B-cell maturation
agent] and CD3. BCMA is highly expressed on myeloma cells and has

2. ASCO 2022 Conference July 19, 2022
limited expression on normal tissue, making it an ideal target for anti-
myeloma strategies. The company is also pursuing Teclistamab for
regulatory approval in the United States and Europe. At ASCO 2022,
Janssen Pharmaceutical presented updated efficacy and safety data from
the ongoing Phase I/II MajesTEC-1 trial (NCT03145181: Phase I, and
NCT04557098: Phase II).
Moreover, the company presented the results Phase I TRIMM-2
study (NCT04108195), in which teclistamab is being investigated in
combination with Darzalex Faspro (daratumumab and hyaluronidase-
fihj) in a poster presentation (Abstract #8032). The MajesTEC-1 trial is a
multicohort, open-label, Phase I/II study looking at the safety and
effectiveness of teclistamab in patients with relapsed/refractory
multiple myeloma who have had at least three prior lines of treatment.
By March 2022, 165 patients had received teclistamab at the
recommended subcutaneous Phase II dose of 1.5 mg/kg, followed by
step-up doses of 0.06 and 0.3 mg/kg in both Phase I (NCT03145181) and
Phase II (NCT04557098) of the trial.
Abstract #8007
The data from the MajesTEC-1 study in Multiple Myeloma Patients who
have experienced three or more prior lines of therapy were presented at
ASCO 2022. Patients with triple class exposed multiple myeloma had
an overall response rate (ORR) of 63% after a median follow-up of 14.1
months, with a complete response (CR) or better achieved in 39.4% of
patients.
Although response duration data is not yet complete, the median
duration of response at this time is 18.4 months and has not been
reached in patients who obtained a CR or better. This data shows that

3. ASCO 2022 Conference July 19, 2022
teclistamab-induced responses were long-lasting and intensified with
time.
The median PFS (progression-free survival) was 11.3 months. Longer
follow-up data revealed no additional safety signs. The most prevalent
grade 3/4 hematologic AEs were neutropenia, anemia, lymphopenia,
and thrombocytopenia, according to 14.1-month follow-up data
reported at ASCO 2022 teclistamab data.
Abstract #8013
Initial data from Cohort C of the MajesTEC-1 Study of Teclistamab in
Patients with Relapsed/Refractory Multiple Myeloma with Prior
Exposure to BCMA Targeted Treatment. The company also released the
first data from Cohort C of the MajesTEC-1 research, which looked at
teclistamab in treating patients with relapsed/refractory multiple
myeloma who had previously been treated with an anti-BCMA.
Cohort C obtained an ORR of 52.5% after a median follow-up of 12.5
months. According to the findings, responses to teclistamab were early
and deepened with time, with comparable response rates in patients
previously treated with Antibody-drug conjugates (ADCs) and CAR-T.
Furthermore, in patients who had previously received anti-BCMA
medication, no dosage reductions or discontinuations were owing to
adverse events (AEs).
Abstract #8032
Janssen also shared updated findings from the Phase I TRIMM-2
trial (NCT04108195), which is testing Teclistamab in combination with
Darzalex Faspro. This trial's findings were presented in a poster session
at ASCO 2022 (Abstract #8032). Patients in the study had a median of five
prior lines of therapy; 75.4% had previously undergone anti-CD38

4. ASCO 2022 Conference July 19, 2022
treatments, and 63.1% were resistant to anti-CD38 treatment. Evaluable
patients had an ORR of 76.5% after a median follow-up of 8.6 months.
Apart from abstracts 8007, 8013, and 8032, the company also revealed
preliminary patient-reported Health-Related Quality of Life Outcomes in
Patients with Relapsed/Refractory Multiple Myeloma treated with
Teclistamab (Abstract #8033). Along with this, a poster (Abstract
#TPS8072) was also presented for the ongoing Phase III MajesTEC-3
study (NCT05083169).
“The MajesTEC-1 study update suggests patients with relapsed or
refractory multiple myeloma receiving teclistamab achieved a deep
response that was also durable. These longer-term data, notably the
overall response rate and progression-free survival, are encouraging in
this heavily pretreated patient population”–Expert Opinion.
"The updated data presented at ASCO support the ongoing evaluation of
teclistamab as a monotherapy and in combination with standard of care
treatments” –Expert Opinion.
Conclusion
CAR T-cell therapy approvals are significant achievements in cancer
research, especially Hematologic-malignancies; however, the promising
results of these therapies come with their own set of challenges,
including manufacturing cost and complexity, the possibility of product
failure, and known safety issues. As of now, only a few bispecific
antibodies in multiple myeloma have been approved by the US Food and
Drug Administration (FDA) for their use in cancer (Amgen’s Blincyto,
Janssen’s Rybrevant, and Immunocore’s Kimmtrak).
J&J is certainly stepping up its game in the multiple myeloma treatment
landscape by exploring novel therapies. With the new approval of CAR-T

5. ASCO 2022 Conference July 19, 2022
treatment (CARVYKTI; February 2022), the company hopes to seize the
lead in bispecific antibody entry in multiple myeloma. Teclistamab, one
of the most anticipated bispecific antibodies in multiple myeloma, is
presently being studied in various monotherapy and combination
studies.
The European Medicines Agency (EMA) has designated teclistamab as
a PRIority MEdicines (PRIME) in January 2021, while the FDA designated
it as a Breakthrough Therapy Designation in June 2021. Janssen's
teclistamab is the first BCMA x CD3 bispecific to be submitted for
approval in Multiple Myeloma to the FDA and EMA.
Janssen filed a Biologics License Application (BLA) to the FDA in
December 2021 requesting approval of teclistamab for the treatment of
patients with Relapsed/Refractory Multiple Myeloma and marketing
authorization applications (MAA) were submitted to the EMA for
teclistamab approval in January 2022. With their investigational drug
Talquetamab (JNJ-64407564) for Relapsed/Refractory Multiple
Myeloma, J&J is also exploring the GPRC5D target.
Bispecific antibody development is making steady progress in the field of
Multiple Myeloma, and the majority of potential candidates are still in
the early phases of development. Overall, this type of therapy has high
expectations, especially because preliminary safety and effectiveness
data have been good. Pfizer (Elranatamab), and Roche (Cevostamab),
are among other pharmaceutical behemoths who are investigating
bispecific antibodies for multiple myeloma, and it will be fascinating to
see which bispecific antibody emerges as victorious in terms of
safety/efficacy, revenue generation, and outperforming the existing
standard of treatment.

6. ASCO 2022 Conference July 19, 2022
The multiple myeloma patient and market share battle is expected to
heat up in the future as bispecific antibodies are likely to compete with
recently approved CAR-T cell therapies and the current standard of
therapies, which includes some of the blockbuster candidates.
Companies- Oncopeptides, GlaxoSmithKline, Bluebird Bio, Janssen
Pharmaceutical, Legend Biotech, AbbVie, Roche (Genentech), Bristol
Myers Squibb, Regeneron Pharmaceuticals, Pfizer, Takeda, Amgen,
SpringWorks Therapeutics, Adicet Bio, Arcellx, Gracell Biotechnologies,
Oricell, Poseida Therapeutics, Precision Biosciences, CRISPR
Therapeutics AG, Collectis SA, Allogene Therapeutics, Fortis
Therapeutics, Novartis, I-Mab/MorphoSys, Cartesian Therapeutics, CASI
Pharmaceuticals, LAVA Therapeutics, and others.
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