https://www.delveinsight.com/asco-conference/article/her3-breast-cancer-trial?utm_source=Promotion&utm_medium=ASCO&utm_campaign=ConferenceCoverage

1. Daiichi’s novel HER3 ADC has Shown To
Have a Spark in HER3 NSCLC, post
success in the HER3 Breast Cancer Trial
Data of Phase I study (NCT03260491) Dose expansion cohort
Phase I study of patitumab deruxtecan in patients with EGFR activating mutated
squamous or non-squamous NSCLC with disease progression during or after
systemic treatment for locally advanced or metastatic disease (Abstract # 9017)
Patritumab deruxtecan is a newer generation ADC that has elicited encouraging
responses with acceptable safety in patients with EGFR TKI-resistant, EGFRm
NSCLC. In 2021, the drug also got Breakthrough Therapy Designation (BTD) in
EGFRm NSCLC patients based on the dose-escalation portion and two cohorts of
a three-cohort phase I study.
On January 28, 2022, the data cut-off date, the confirmed overall response rate
(ORR) by blinded independent central review (BICR) per RECIST 1.1 was 28.6%
among patients with identified genomic driver alterations (n = 21). The disease
control rate (DCR) in this cohort of patients was 76.2%, and the median time to

2. response was 2.8 months. The median duration of response (DOR) was 9.4
months, and the median progression-free survival (PFS) was 10.8 months.
In patients without identified genomic driver alterations (n = 26), the confirmed
ORR was 26.9%, and the DCR was 73.1%. The median DOR was 9.6 months, and
the median PFS was 4.2 months. The median time to response was 2.1 months.
The median follow-up time was 19.7 months.
TEAEs associated with death occurred in 14.9% of patients, and 40.4% of
patients experienced serious AEs.
KOL insights
“These results demonstrate the promising clinical activity of patritumab
deruxtecan in patients with NSCLC harboring a broad range of genomic
alterations or without identified genomic alterations. They warrant further
clinical evaluation.”–Expert Opinion.
Conclusion
HER3 is one of 4 receptor tyrosine kinases (RTKs) that make up the HER family.
HER3 expression has been noted in many types of cancer, including breast,
gastric, colorectal, bladder, prostate, ovarian, and NSCLC. But till today, the
precise function of HER3 overexpression across these tumor types is not entirely
clear. In NSCLC, HER3 overexpression in primary tumors has been associated
with metastatic progression and decreased relapse-free survival time.
Investigators detected HER3 expression via immunohistochemistry (IHC)
analysis. Despite the rationale for HER3 inhibition, till today, not a single drug
has been approved by the FDA with this mechanism. Since HER3 has limited
intrinsic kinase activity, small molecule kinase inhibitors are unlikely to be
useful, which has led the investigators to explore the development of HER3-
targeted mAbs. Because most of the HER3-directed mAbs evaluated in clinical
studies have demonstrated limited clinical activity, the focus has shifted to
novel designs such as ADCs.
The current standard of care in EGFR-mutated NSCLC, after disease progression
on EGFR TKI therapy, the treatment approach includes genotype-directed
therapy targeting a known resistance mechanism or chemotherapy. HER3-
directed deruxtecan demonstrated clinical activity spanning known and

3. unknown EGFR TKI resistance. As there are currently no approved targeted
therapy for the treatment of patients who progress on EGFR TKI therapy,
paritumab deruxtecan being a HER3 directed therapy can help fulfill the unmet
medical need of this patient segment, and if the further data continues to be
positive, this agent may be able to replace the cytotoxic chemotherapy in these
patients.
Companies- Boehringer Ingelheim, Roche, Merck, AbbVie, Daiichi Sankyo,
Chugai Pharmaceutical, Regeneron, Sanofi, Janssen, and others.
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