Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]
July 20 2023 - 4:14PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN
PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of July 2023.
Commission File Number: 001-39071
ADC Therapeutics SA
(Exact name of registrant as specified in its
charter)
Biopôle
Route de la Corniche 3B
1066 Epalinges
Switzerland
(Address of principal executive office)
Indicate by check mark whether the registrant files
or will file annual reports under cover of Form 20-F or Form 40-F:
INFORMATION CONTAINED IN THIS REPORT ON FORM
6-K
On July 20, 2023, ADC Therapeutics SA (the “Company”)
announced that it plans to discontinue the Phase 2 LOTIS-9 clinical trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) and rituximab
(Lonca-R) in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Given the challenges of defining
the addressable segment of the difficult-to-treat unfit or frail DLBCL patient population, many with significant active underlying co-morbidities,
the benefit-risk profile does not support continuation of the LOTIS-9 trial. Following a meeting on July 19, 2023, the U.S. Food and Drug
Administration (FDA) placed a partial clinical hold on the trial for new patient enrollment but will allow patients already on therapy
who are deriving clinical benefit to remain on therapy after being reconsented. Following treatment of any reconsenting patients, the
Company will conduct the necessary steps to conclude the trial and does not plan to continue studying this regimen in the unfit or frail
previously untreated DLBCL patient population.
INCORPORATION BY REFERENCE
This Report on Form 6-K shall be deemed to be incorporated
by reference into the registration statements on Form F-3 (Registration Nos. 333-267293, 333-267295 and 333-270570) of ADC Therapeutics
SA and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently
filed or furnished.
SIGNATURE
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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ADC Therapeutics SA |
Date: July 20, 2023 |
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By: |
/s/ Peter J. Graham |
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Name: |
Peter J. Graham |
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Title: |
Chief Legal Officer |
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