ADC Therapeutics Announces ZYNLONTA® Updates in Japan

Japanese Phase 2 results showed a 58.1% overall response rate, while an exclusive sublicense adds a commercialization partner.

Rhea-AI Summary

ADC Therapeutics (ADCT) announced that partner Tanabe Pharma filed for Japanese approval of ZYNLONTA for previously treated diffuse large B-cell lymphoma.

The application covers patients whose disease returned or resisted treatment after two or more lines of systemic therapy. In the Japanese Phase 2 study, the overall response rate was 58.1%, including a 41.9% complete response rate. Median response duration was not reached at a median follow-up of 15.21 months; no new safety concerns were identified.

Tanabe Pharma also signed an exclusive commercialization sublicense with Nippon Shinyaku for Japan. ADC Therapeutics' existing license includes near-term milestones tied to application filing acceptance and the first commercial sale in the Tanabe Pharma territory.

5 points · 0 major

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Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

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0 major · 2 points

How the balance works

Positive

• Moderate pointJapanese approval application filed for ZYNLONTA in relapsed or refractory DLBCL after two or more systemic therapies.
• Moderate pointOverall response rate of 58.1% included a 41.9% complete response rate in the Japanese Phase 2 study.
• Moderate pointExclusive Nippon Shinyaku sublicense adds Japanese commercialization support for ZYNLONTA's potential introduction.
• Minor pointMedian response duration not reached at a median follow-up of 15.21 months in the Japanese Phase 2 study.
• Minor pointNo new safety concerns identified; Japanese study findings were consistent with the pivotal global LOTIS-2 study.

Negative

• Minor pointJapanese regulatory approval remains pending, with Tanabe Pharma responsible for obtaining approval under the current application.
• Minor pointNear-term license milestones remain conditional on application filing acceptance and first commercial sale in the Tanabe Pharma territory.

Key Figures

Overall response rate: 58.1% Complete response rate: 41.9% Median duration of response: Not reached +1 more

Overall response rate

58.1%

Phase 2 portion of Japanese study

Complete response rate

41.9%

Phase 2 portion of Japanese study

Median duration of response

Not reached

At median follow-up of 15.21 months

Median follow-up

15.21 months

Phase 2 portion of Japanese study

Key Terms

antibody drug conjugates, marketing authorization application, overall response rate, complete response rate

4 terms

antibody drug conjugates medical

"pioneer in the field of antibody drug conjugates (ADCs)"

Antibody drug conjugates are targeted medicines that combine an antibody, which seeks out specific markers on diseased cells, with a powerful drug that is released only when the antibody binds its target. Think of it as a guided missile that delivers a toxic payload directly to its target, reducing damage to healthy cells; investors watch them because successful ADCs can offer high-value, niche treatments and drive strong revenue and patent-based protection for developers.

marketing authorization application regulatory

"filed a marketing authorization application with Japan's Ministry"

A marketing authorization application is a formal request submitted to a government regulator asking permission to sell a prescription medicine or medical product in a country or region. Think of it like asking for a business license after showing evidence the product is safe and works; investors care because approval determines whether the product can generate sales, how soon revenue starts, and how much regulatory risk and uncertainty remains.

overall response rate medical

"demonstrated an overall response rate of 58.1%"

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.

complete response rate medical

"including a complete response rate of 41.9%"

Complete response rate is the percentage of patients in a clinical trial whose measurable signs of disease disappear after treatment, as judged by predefined medical tests. For investors, a higher complete response rate is a strong signal that a drug works well in the trial setting, improving chances of regulatory approval and commercial success — like seeing most lightbulbs in a new batch actually turn on before deciding to buy the factory.

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Licensing partner, Tanabe Pharma, filed for Japanese approval of ZYNLONTA (MT-2111) for relapsed or refractory DLBCL based on encouraging Japanese Phase 1/2 clinical results

Tanabe Pharma entered into exclusive sublicensing agreement with Nippon Shinyaku, bringing established Japanese oncology expertise and commercial capabilities to support potential introduction in Japan

Supports anticipated regulatory and commercial milestones for ADC Therapeutics

LAUSANNE, Switzerland, Oct. 29, 2026 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced that its Japanese licensing partner, Tanabe Pharma Corporation (formerly Mitsubishi Tanabe Pharma Corporation), filed a marketing authorization application with Japan's Ministry of Health, Labor and Welfare on October 29, 2026, for ZYNLONTA® (loncastuximab tesirine-lpyl) to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. In addition, Tanabe Pharma has entered into an exclusive sublicensing agreement with Nippon Shinyaku Co., Ltd., for the commercialization of ZYNLONTA in Japan.

Recently, encouraging results from the Phase 1/2 MT-2111-A-101 bridging study evaluating ZYNLONTA monotherapy in Japanese patients with relapsed or refractory DLBCL were presented at the Japanese Society of Hematology meeting. In the Phase 2 portion of the study in Japan, ZYNLONTA demonstrated an overall response rate of 58.1%, including a complete response rate of 41.9%, with median duration of response not reached at a median follow-up of 15.21 months. The findings were consistent with the pivotal LOTIS-2 global study, with no new safety concerns identified. Based on these results, Tanabe Pharma filed the marketing authorization application for ZYNLONTA in Japan.

"This is a significant step forward in our efforts to expand ZYNLONTA's global reach to bring this important treatment option to more patients with B-cell malignancies," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "Japan represents a meaningful opportunity for ZYNLONTA, and we're encouraged by the progress our partners are making toward its potential introduction in this market. We look forward to building on this momentum as ZYNLONTA advances toward its next regulatory and commercial milestones."

Building on ADC Therapeutics' exclusive licensing partnership with Tanabe Pharma established in 2022, Nippon Shinyaku will bring its established hematology/oncology commercial expertise to support ZYNLONTA's potential introduction in Japan. Nippon Shinyaku has a strong commercial and field medical presence in Japan, with a track record of successfully introducing innovative therapies developed by global pharmaceutical companies to the Japanese market. Under the sublicensing agreement, Tanabe Pharma will remain responsible for ongoing development activities and for obtaining regulatory approval in Japan under the current application.

Under the existing license agreement between ADC Therapeutics and Tanabe Pharma as previously disclosed, near-term milestones include acceptance of filing a marketing authorization application for ZYNLONTA in the Tanabe Pharma territory for the treatment of DLBCL and the first commercial sale of ZYNLONTA in the Tanabe Pharma territory for the treatment of DLBCL.

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.

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. 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 Tanabe's marketing authorization application filed with Japan's Ministry of Health for ZYNLONTA will be accepted, the timing and potential approval of the marketing authorization application for ZYNLONTA in Japan, the timing and payment of future regulatory and commercial milestones related to Japan, Nippon Shinyaku ability to successfully commercialize ZYNLONTA in Japan and the amount of future revenue in Japan and related payments to ADCT; 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; our ability to identify and execute on potential regulatory and compendia pathways; the timing, content and outcome of meetings with and feedback or other communications provided by regulatory authorities including U.S. FDA including our ability to adequately address the serious concerns related to the LOTIS-5 trial results raised by the FDA at the recent pre-sBLA submission meeting; the timing, submission and outcome of an sBLA 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 and into earlier lines of therapy; 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 data and potential compendia inclusion; future regulatory strategy for a Phase 3 trial for the combination of ZYNLONTA plus glofitamab; our expected revenue growth in 2027 and the Company's ability to sustain or grow ZYNLONTA® revenue in the future; our expected cash runway into 2029; changes in our regulatory and commercial strategy; 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 or maintain 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; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities; uncertainties related to a potential change in domicile from Switzerland to Delaware, including the outcome of tax analyses associated with such redomiciliation, the receipt of requisite shareholder approval, and the ability to complete the redomiciliation on the anticipated terms and timeline, if at all; 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.

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

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SOURCE ADC Therapeutics SA

FAQ

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What Japanese approval is ADC Therapeutics seeking for ZYNLONTA?

Partner Tanabe Pharma filed for approval of ZYNLONTA for relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. The marketing authorization application was filed with Japan's Ministry of Health, Labor and Welfare on October 29, 2026.

What did the Japanese ZYNLONTA Phase 2 study show?

The Japanese Phase 2 study showed an overall response rate of 58.1%, including a complete response rate of 41.9%. Median duration of response was not reached at a median follow-up of 15.21 months. No new safety concerns were identified, and findings were consistent with the pivotal global LOTIS-2 study.

Who will handle ZYNLONTA development and commercialization in Japan?

Tanabe Pharma remains responsible for ongoing development and obtaining Japanese regulatory approval, while Nippon Shinyaku holds the exclusive commercialization sublicense for Japan. The arrangement builds on ADC Therapeutics' exclusive licensing partnership with Tanabe Pharma established in 2022.