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ADC Therapeutics Announces Completion of Enrollment in LOTIS-7 Phase 1b ZYNLONTA® Combination Trial

(Very Positive)
Tags

ADC Therapeutics (NYSE: ADCT) completed enrollment in the LOTIS-7 Phase 1b trial of ZYNLONTA plus glofitamab in relapsed or refractory DLBCL. The study includes 100 patients at a 150 µg/kg ZYNLONTA dose across 30 sites, with full data expected in Q4 2026.

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Positive

  • LOTIS-7 enrollment completed with 100 r/r DLBCL patients at 150 µg/kg
  • Previously reported ORR 89.8% and CR 77.6% in 49 efficacy-evaluable patients
  • Enrollment across 30 sites with 70% of patients in US and 30% in EU
  • Primary and multiple secondary efficacy endpoints defined, including survival outcomes

Negative

  • Current efficacy and safety data based on only 49 efficacy-evaluable patients
  • Full LOTIS-7 data not expected until the fourth quarter of 2026

News Market Reaction – ADCT

+3.88%
15 alerts
+3.88% Session close to close
+9.3% Peak in 28 hr 8 min
$150.09M Market Cap
0.2x Rel. Volume

In the Jun 30 session, ADCT gained 3.88%, reflecting a moderate positive market reaction. Argus tracked a peak move of +9.3% during that session. Our momentum scanner triggered 15 alerts that day, indicating notable trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement confirms LOTIS‑7 is fully enrolled at the selected dose in 100 r/r DLBCL patients,...
Analysis

This announcement confirms LOTIS‑7 is fully enrolled at the selected dose in 100 r/r DLBCL patients, following promising response rates. It advances the ZYNLONTA combination strategy, but investors should watch for full data and any evolving regulatory pathway.

Key Figures

Patients at selected dose: 100 patients ZYNLONTA dose: 150 µg/kg Trial sites: 30 sites +5 more
8 metrics
Patients at selected dose 100 patients r/r DLBCL in LOTIS-7 at 150 µg/kg ZYNLONTA plus glofitamab
ZYNLONTA dose 150 µg/kg Selected combination dose with glofitamab in LOTIS-7 Phase 1b
Trial sites 30 sites LOTIS-7 enrollment across US and EU centers
US enrollment share 70% Proportion of LOTIS-7 patients enrolled in the US
EU enrollment share 30% Proportion of LOTIS-7 patients enrolled in the EU
Relapsed patients 46% Share of LOTIS-7 population with relapsed r/r DLBCL
Primary refractory patients 54% Share of LOTIS-7 population with primary refractory r/r DLBCL
Overall response rate 89.8% Previously reported ORR in 49 efficacy-evaluable LOTIS-7 patients

Historical Context

5 past events · Latest: Jun 24 (Neutral)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Jun 24 Strategic reorganization Neutral -7.0% Reorganization with 17% workforce reduction and cost‑saving plan around ZYNLONTA.
Jun 03 Phase 3 clinical data Positive -57.1% LOTIS‑5 met primary endpoint with improved progression‑free survival vs R‑GemOx.
May 04 Quarterly earnings Neutral -3.9% Q1 2026 financials with $20M net product revenue and cash runway into 2028.
May 01 Equity grants Neutral +1.3% Inducement stock option grants to new employees under NYSE exemption.
Apr 27 Earnings call notice Neutral -4.6% Announcement of upcoming Q1 2026 results conference call and webcast.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent ADCT news, including strong clinical and operational updates, has often been followed by negative share-price reactions.

Key Terms

phase 1b, overall response rate, progression-free survival, pharmacokinetics, +2 more
6 terms
phase 1b medical
"LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy"
"Phase 1b" is an early stage in testing a new medical treatment or vaccine, where it is given to a small group of people to evaluate its safety and determine the right dose. For investors, this phase signals progress in development, indicating the treatment is advancing through initial safety checks, which can influence expectations for future success and potential market impact.
overall response rate medical
"Secondary endpoints include overall response rate, duration of response, complete"
Overall response rate is the percentage of patients in a clinical study whose measurable disease shrinks or disappears after receiving a treatment. Investors watch it like a product’s “hit rate” because higher response rates can signal a drug’s effectiveness, boost chances of regulatory approval and market demand, and affect a company’s future revenue prospects, similar to how a higher batting average suggests a more reliable player.
progression-free survival medical
"relapse free survival, progression-free survival, and overall survival, as well"
Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.
pharmacokinetics medical
"overall survival, as well as pharmacokinetics and immunogenicity. As part"
Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.
immunogenicity medical
"overall survival, as well as pharmacokinetics and immunogenicity. As part"
Immunogenicity is the ability of a substance, such as a vaccine or medication, to provoke an immune response in the body. It matters to investors because high immunogenicity can affect the effectiveness and safety of a product, potentially leading to increased costs or regulatory challenges. Understanding immunogenicity helps assess the long-term viability and market potential of pharmaceutical and biotech investments.
intravenous immunoglobulin medical
"anti-infective prophylaxis, intravenous immunoglobulin (in patients experiencing"
Intravenous immunoglobulin (IVIG) is a medicine made from pooled antibodies collected from donated blood and delivered directly into a vein to boost or calm a patient’s immune system, acting like a ready-made squad of defenders or a dampener for an overactive alarm. It matters to investors because IVIG is complex and costly to produce, relies on donor supply and tight regulation, and can drive significant revenue or supply risk for companies that manufacture, price, or distribute it.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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100 r/r DLBCL patients treated at the selected 150 µg/kg dose of ZYNLONTA® plus glofitamab

Full data expected in fourth quarter of 2026

LAUSANNE, Switzerland, June 30, 2026 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced the completion of enrollment in the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of ZYNLONTA® (loncastuximab tesirine-lpyl) in combination with the bispecific antibody glofitamab (COLUMVI®) in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (r/r DLBCL).

ADC Therapeutics logo

LOTIS-7 trial enrollment is now complete with 100 r/r DLBCL patients dosed at the selected 150 µg/kg dose of ZYNLONTA plus glofitamab. Enrollment occurred in 30 total sites with 70% of patients in the US and 30% in the EU. The study enrolled patients with baseline characteristics similar to other bispecific combination studies in this space and included 46% relapsed and 54% primary refractory patients with a median age of 66 years.

Primary endpoints of the study include safety and tolerability. Secondary endpoints include overall response rate, duration of response, complete response, relapse free survival, progression-free survival, and overall survival, as well as pharmacokinetics and immunogenicity. As part of the study protocol, anti-infective prophylaxis, intravenous immunoglobulin (in patients experiencing B-cell loss with an increased risk of infection) and vaccination are strongly recommended.

"We are excited by the previously reported data from this study which demonstrated an 89.8% ORR and 77.6% CR and a manageable safety profile across the 49 efficacy-evaluable patients with a minimum of 6 months of follow-up," said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. "We continue to believe this ZYNLONTA combination has the potential to be the best-in-class bispecific antibody-based combination in 2L+ DLBCL. With enrollment now complete, we look forward to sharing more comprehensive results from LOTIS-7 later this year."

Further to the previously reported results from LOTIS-7 demonstrating promising clinical activity for the combination of ZYNLONTA plus glofitamab in patients with r/r DLBCL, the Company plans to share full data from LOTIS-7 at a medical meeting and submit the results for publication by the end of 2026. In addition, the Company plans to assess potential regulatory and compendia pathways for the combination.

About LOTIS-7

LOTIS-7 is a Phase 1b global multicenter, multi-arm study in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) including Part 1 (dose escalation) and Part 2 (dose expansion). The three dosing arms include ZYNLONTA plus polatuzumab vedotin, ZYNLONTA plus glofitamab, and ZYNLONTA plus mosunetuzumab T-cell-engaging bispecific monoclonal antibodies (BsAbs). Enrollment in LOTIS-7 includes Part 1 of the study with a 3+3 dose escalation in 3L+ heavily pre-treated patients with ZYNLONTA doses starting at 90 µg/kg and then proceeding to 120 µg/kg and 150 µg/kg. Part 2 includes dose expansion in 2L+ large B-cell lymphoma in the ZYNLONTA plus glofitamab arm at dose levels determined from Part 1 (120 µg/kg and 150 µg/kg of ZYNLONTA plus the approved dosing of glofitamab).

For more information about the LOTIS-7 trial, visit clinicaltrials.gov (NCT04970901).

About ZYNLONTA®

ZYNLONTA® is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) 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 diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), 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.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

About ADC Therapeutics

ADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), transforming treatment for patients through our focused portfolio with ZYNLONTA (loncastuximab tesirine-lpyl).

ADC Therapeutics' CD19-directed ADC ZYNLONTA 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.

Headquartered in Lausanne (Biopôle), Switzerland, with operations in New Jersey, ADC Therapeutics is focused on driving innovation in ADC development with specialized capabilities from clinical to manufacturing and commercialization. Learn more at https://adctherapeutics.com/ and follow us on LinkedIn.

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. 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: whether future LOTIS-7 results will be consistent with or different from the prior disclosure, the timing, results and publication of the full LOTIS-7 trial; the adequacy of the LOTIS-5 clinical trial data to support full regulatory approval and our ability to maintain accelerated approval in the United States and foreign jurisdictions for our product; the timing, content and outcome of meetings with and feedback or other communications provided by regulatory authorities including U.S. FDA; the timing, submission and acceptance of an sBLA submission related to LOTIS-5 and potential approval; the actual and perceived benefit-risk profile for ZYNLONTA as studied in the LOTIS-5 trial; the assessment of the data from LOTIS-5 study, including additional analyses of outcomes observed for safety, efficacy and within key geographic regions and across certain patient sub-populations; the path for full regulatory approval for ZYNLONTA in the United States and foreign jurisdictions; our ability to identify and execute value-maximizing options and the cost and impact of such options; our expected cash runway into at least 2028; our ability to comply with the terms of our indebtedness; changes in our regulatory and commercial strategy; the Company's ability to sustain or grow ZYNLONTA® revenue in the United States and potential peak revenue; the ability of our partners to commercialize ZYNLONTA® in foreign markets, the timing and amount of future revenue and payments to us from such partnerships and their ability to obtain regulatory approval for ZYNLONTA® in foreign jurisdictions; the timing and results of the Company's clinical trials; the timing, publication and results of investigator-initiated trials including those studying FL and MZL and the potential regulatory and/or compendia strategy and the future opportunity; the timing and outcome of regulatory submissions for the Company's products or product candidates; actions by the FDA or foreign regulatory authorities; projected revenue and expenses; the Company's indebtedness, including HealthCare Royalty Management and Blue Owl and Oaktree facilities, and the restrictions imposed on the Company's activities by such indebtedness, the ability to comply with the terms of the various agreements and repay such indebtedness and the significant cash required to service such indebtedness; and the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities; and the uncertainties of international trade policies, including tariffs, sanctions, trade barriers and most favored nation drug pricing and the potential impact they may have on our business, financial condition, and results of operations. 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 10-K and in the Company's other periodic and current reports and filings with the U.S. Securities and Exchange Commission. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document.

CONTACT:

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

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/adc-therapeutics-announces-completion-of-enrollment-in-lotis-7-phase-1b-zynlonta-combination-trial-302813948.html

SOURCE ADC Therapeutics SA

FAQ

What did ADC Therapeutics (NYSE: ADCT) announce about the LOTIS-7 trial on June 30, 2026?

ADC Therapeutics announced completion of enrollment in the LOTIS-7 Phase 1b trial of ZYNLONTA plus glofitamab in r/r DLBCL. According to ADC Therapeutics, 100 patients have been dosed at the selected 150 µg/kg ZYNLONTA dose across 30 study sites.

What are the key design features and endpoints of ADC Therapeutics' LOTIS-7 Phase 1b trial (ADCT)?

LOTIS-7 is an open-label Phase 1b trial evaluating ZYNLONTA plus glofitamab in r/r DLBCL. According to ADC Therapeutics, primary endpoints are safety and tolerability, with secondary endpoints including response rates, survival measures, pharmacokinetics, and immunogenicity, alongside recommended anti-infective prophylaxis and vaccination.

What early efficacy results have been reported for ZYNLONTA plus glofitamab in r/r DLBCL (ADCT)?

Early LOTIS-7 data showed an 89.8% overall response rate and 77.6% complete response in 49 patients. According to ADC Therapeutics, these efficacy-evaluable patients had at least six months of follow-up and the combination demonstrated what is described as a manageable safety profile.

When is ADC Therapeutics expecting full LOTIS-7 data for ZYNLONTA plus glofitamab (ADCT)?

Full LOTIS-7 data are expected in the fourth quarter of 2026. According to ADC Therapeutics, the company plans to present the results at a medical meeting, submit them for publication by year-end 2026, and assess potential regulatory and compendia pathways.

How many patients and regions are included in ADC Therapeutics' LOTIS-7 trial of ZYNLONTA (ADCT)?

The completed LOTIS-7 enrollment includes 100 r/r DLBCL patients treated at 150 µg/kg ZYNLONTA plus glofitamab. According to ADC Therapeutics, enrollment occurred at 30 sites, with about 70% of patients in the United States and 30% in the European Union.

What patient characteristics are reported in the LOTIS-7 ZYNLONTA combination trial (ADCT)?

LOTIS-7 enrolled relapsed or refractory DLBCL patients with characteristics similar to other bispecific combination studies. According to ADC Therapeutics, 46% were relapsed and 54% primary refractory, with a median age of 66 years in this Phase 1b population.

How does ADC Therapeutics view the potential of ZYNLONTA plus glofitamab in 2L+ DLBCL (ADCT)?

ADC Therapeutics states it continues to believe the ZYNLONTA plus glofitamab regimen may be a best-in-class bispecific-based combination in 2L+ DLBCL. According to the company, this view is supported by previously reported response rates and what it describes as a manageable safety profile.