ADC Therapeutics Announces Plan to Discontinue the Phase 2 LOTIS-9 Clinical Trial of ZYNLONTA® (loncastuximab tesirine-lpyl) and Rituximab in Unfit or Frail Previously Untreated DLBCL Patients

Rhea-AI Summary

ADC Therapeutics SA (NYSE: ADCT) to discontinue Phase 2 LOTIS-9 clinical trial for ZYNLONTA® and rituximab in unfit or frail patients with previously untreated DLBCL due to challenges in defining the addressable segment and the benefit-risk profile not supporting continuation. FDA places partial clinical hold on trial for new patient enrollment.

Positive

• The company is taking a proactive approach by discontinuing the trial to reevaluate the benefit-risk profile, which demonstrates a commitment to patient safety and ethical clinical practices.

Negative

• The discontinuation of the trial may lead to a temporary setback in the development of a potential treatment for unfit or frail patients with previously untreated DLBCL, impacting the company's research and development pipeline.

LAUSANNE, Switzerland, July 20, 2023 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today 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, including many patients with significant active underlying co-morbidities, the benefit-risk profile does not support continuation of the LOTIS-9 trial.

Following a meeting yesterday, 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.

About (loncastuximab tesirine-lpyl)

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com.

About ADC Therapeutics

ADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs). The Company is advancing its proprietary ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.

ADC Therapeutics’ CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents and in earlier lines of therapy. In addition to ZYNLONTA, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development.

ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please visit https://www.adctherapeutics.com/ and follow the company on Twitter and LinkedIn.

ZYNLONTA^® is a registered trademark of ADC Therapeutics SA.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements concerning the Company’s intentions regarding its LOTIS-9 or other clinical trials and any actions taken by regulatory authorities relating to the same. In some cases you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “would,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “seem,” “seek,” “future,” “continue,” or “appear” or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the nature, frequency and severity of adverse events; the ability to complete clinical trials on expected timelines, if at all; the outcome of clinical trials or the sufficiency of results from such clinical trials; the timing and results of the Company’s or its partners’ research projects or clinical trials including LOTIS 5, 7 and 9, ADCT 901, 601 and 602; and the timing and outcome of regulatory submissions and actions by the FDA or other regulatory agencies with respect to the Company’s products or product candidates. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the “Risk Factors” section of the Company's Annual Report on Form 20-F and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document. The Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

CONTACTS:

Investors
Eugenia Litz
ADC Therapeutics
Eugenia.Litz@adctherapeutics.com
+44 7879 627205
+1 908-723-2350

Media
Nicole Riley
ADC Therapeutics
Nicole.Riley@adctherapeutics.com
+1 862-926-9040

FAQ

Why is ADC Therapeutics discontinuing the Phase 2 LOTIS-9 clinical trial?

ADC Therapeutics is discontinuing the trial due to challenges in defining the addressable segment of the unfit or frail DLBCL patient population and the benefit-risk profile not supporting continuation.

What action did the FDA take regarding the trial?

The 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.