About ZYNLONTA and the LOTIS Trial

The U.S. FDA has granted the accelerated approval of ZYNLONTA (loncastuximab tesirine-lpyl) on April 23, 2021  as a single-agent for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma and high-grade B-cell lymphoma, a key point of differentiation on the label.

ZYNLONTA became commercially available last week.

As of May 5, 2021, ZYNLONTA was added to the NCCN guidelines with a category 2A recommendation for third-line plus DLBCL, including DLBCL arising from low-grade lymphoma such as follicular lymphoma (FL) and marginal zone lymphoma (MZL).

A Phase 3 LOTIS-5 clinical trial is evaluating ZYNLONTA in combination with rituximab in second-line patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant. This trial will fulfill the post-marketing approval requirement with the FDA for a confirmatory study. 

The pivotal Phase 2 LOTIS-3 clinical trial of ZYNLONTA in combination with ibrutinib for relapsed or refractory DLBCL patients is intended to support the submission of a supplemental Biologics License Application (BLA) for ZYNLONTA in combination with ibrutinib.

Additional 2021 Trials to Potentially Expand the ZYNLONTA Opportunity:

• Pivotal Phase 2 clinical trial in follicular lymphoma (FL).
• Trial to evaluate ZYNLONTA in combination with multiple other drugs in B-cell non-Hodgkin lymphoma (NHL).
• A dose-finding study of ZYNLONTA in combination with R-CHOP in frontline DLBCL.

ZYNLONTA 2021 Expected Milestones:

• Initiate a pivotal Phase 2 clinical trial of ZYNLONTA in FL in the second quarter of 2021.
• Report updated data from the Phase 1 clinical trial of ZYNLONTA in combination with ibrutinib in relapsed or refractory DLBCL in the second quarter of 2021.
• Initiate the dose-finding study of ZYNLONTA in first-line DLBCL with R-CHOP in the second half of 2021.
• Initiate the clinical trial to evaluate ZYNLONTA in multiple combinations in B-cell non-Hodgkin lymphoma in the second half of 2021.
• Complete enrollment in the pivotal Phase 2 trial of ZYNLONTA in combination with ibrutinib in the second half of 2021.
• Complete safety lead-in of Phase 3 LOTIS-5 confirmatory study of ZYNLONTA in combination with rituximab in the second half of 2021.

CAMI

Report interim results from the pivotal Phase 2 clinical trial of Cami in HL in the second quarter of 2021.

Earlier-Stage Pipeline

• File Investigational New Drug (IND) application for ADCT-901, targeting KAAG1 in the second quarter of 2021.
• Initiate a Phase 1b combination study of ADCT-601, targeting AXL, in multiple solid tumors in the first half of 2022.

Camidanlumab Tesirine (Cami)

The pivotal Phase 2 clinical trial evaluating the efficacy and safety of Cami in patients with relapsed or refractory Hodgkin lymphoma (HL) has completed enrollment and is continuing to follow patients. The Company will present data from this study at an upcoming congress.

The Phase 1b clinical trial of Cami in combination with pembrolizumab in selected advanced solid tumors is an open-label, dose-escalation, and dose-expansion trial evaluating the safety, tolerability, pharmacokinetics, and antitumor activity of Cami in combination with pembrolizumab, a checkpoint inhibitor. 

ADC Therapeutics First Quarter 2021 Financial Results 

Cash and cash equivalents were $383.1 million as of March 31, 2021, compared to $439.2 million as of December 31, 2020. In the coming days, the Company will be drawing down $50 million associated with its Convertible Credit Facility with Deerfield, which was contingent upon ZYNLONTA approval.

Research and Development (R&D) expenses were $39.2 million for the quarter ended March 31, 2021, compared to $35.4 million for the same quarter in 2020. The increase is from investments in exploring the potential of ZYNLONTA in earlier lines of treatment and histologies and advance the portfolio. As a result of these initiatives, employee headcount and share-based compensation expense increased.

Selling and Marketing (S&M) expenses were $13.9 million as compared to $2.6 million for the same quarter in 2020. The increase is related to the build-out of the Company’s commercial organization and preparation activities for the anticipated launch of ZYNLONTA in 2021.

General & Adminstrative (G&A) expenses were $17.6 million for the first 2021 quarter, compared to $5.9 million in 2020.

Net loss was $51.5 million, or $0.67 per basic and diluted share compared to $43.5 million, or a net loss of $0.85 per basic and diluted share, for the same quarter in 2020.

The net loss for the quarter includes a $21.2 million non-cash gain related to the changes in fair value of derivatives associated with the convertible loans under the Convertible Credit Facility with Deerfield. The decrease in fair value was driven by the decrease in the Company’s share price from December 31, 2020. In addition, net loss included share-based compensation expense of $14.0 million for the quarter ended March 31, 2021, compared to $3.8 million for the same quarter in 2020. 

ADC Therapeutics Conference Call Details

ADC Therapeutics management hosted a conference call ay at 8:30 a.m. Eastern Time. A live webcast of the presentation will be available under “Events and Presentations” in the Investors section of the ADC Therapeutics website. The archived webcast will be available for 30 days following the call.

ADC Therapeutics Stock

Prohost Observations 

ADC Therapeutics is a company worth considering now that it has moved from a development-stage firm to a revenue-expected firm following the approval of its ADC product ZYNLONTA for a broad population with DLBL. We intend to follow up on this firm which has already offered a proof of concept about the safety, efficacy, feasibility and superiority of its antibody-drug conjugate in cancer treatment.   

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