LAUSANNE, Switzerland - ADC Therapeutics SA (NYSE: ADCT) has successfully completed the dose escalation part of its Phase 1b LOTIS-7 clinical trial, assessing the safety and efficacy of ZYNLONTA® in combination with bispecific antibodies for treating B-cell non-Hodgkin lymphoma. The trial found no dose-limiting toxicities and displayed early signs of anti-tumor activity.
The trial, which involved heavily pre-treated patients with relapsed or refractory B-cell non-Hodgkin lymphoma, did not register any dose-limiting toxicities or severe cases of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) across all participants. Encouragingly, the majority of patients showed evidence of anti-tumor activity, including those with diffuse large B-cell lymphoma, follicular lymphoma, and marginal zone lymphoma.
Following these results, all three dose levels tested—90, 120, and 150 µg/kg—have been approved for further investigation. The trial has now progressed to Part 2, focusing on dose expansion with ZYNLONTA administered in combination with glofitamab at the 120 µg/kg and 150 µg/kg dose levels in patients with 2L+ DLBCL.
ADC Therapeutics' Chief Medical Officer, Mohamed Zaki, MD, PhD, expressed optimism about the trial's advancement, particularly in treating 2L+ DLBCL patients. The favorable toxicity profile observed thus far is seen as promising, especially considering the challenges associated with current CAR-T and bispecific therapies, which commonly induce CRS.
The LOTIS-7 study is a global, multicenter trial that includes a 3+3 dose escalation in 3L/3L+ heavily pre-treated patients. The trial's next phase will further investigate the combination of ZYNLONTA with glofitamab and mosunetuzumab, both T-cell-engaging bispecific monoclonal antibodies.
ZYNLONTA® is a CD19-directed antibody drug conjugate approved by the FDA and the European Medicines Agency for adult patients with relapsed or refractory large B-cell lymphoma after at least two lines of systemic therapy. ADC Therapeutics, headquartered in Lausanne, Switzerland, specializes in the development of antibody drug conjugates for cancer treatment.
The company's forward-looking statements include the anticipation of continued progress in clinical trials and the potential for broader use of ZYNLONTA in the treatment of DLBCL. This news is based on a press release statement from ADC Therapeutics.
InvestingPro Insights
As ADC Therapeutics SA (NYSE: ADCT) progresses with its clinical trials, the company's financial health and stock performance remain critical factors for investors. According to InvestingPro data, the company has a market capitalization of $365.61 million, reflecting its size within the biotech industry. Despite the encouraging clinical results, the company's gross profit margin for the last twelve months as of Q4 2023 stands at -80.72%, underscoring the challenges in achieving profitability. Furthermore, with a negative P/E ratio of -1.52 for the same period, the company's earnings do not yet support its current stock price, a common scenario for many growth-focused biotech firms.
InvestingPro Tips highlight several aspects of ADC Therapeutics' financial and stock performance. The company has been quickly burning through cash and suffers from weak gross profit margins, which are crucial considerations given the significant costs associated with drug development and clinical trials. Additionally, the stock price has been quite volatile, with a substantial price uptick of 440.24% over the last six months, which could attract investors looking for high-growth opportunities despite the risks. However, analysts do not anticipate the company will be profitable this year, underscoring the speculative nature of investing in ADC Therapeutics at this stage.
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