Seven deaths and five respiratory-related, treatment-emergent adverse events in a group of 40 aged and very unwell cancer patients rang alarm bells for ADC Therapeutics SA. The company has voluntarily paused enrollment in its phase II Lotis-9 study of Zynlonta (loncastuximab tesirine-lpyl) and rituximab (Lonca-R) for treating previously untreated diffuse large B-cell lymphoma in those who are considered frail or unfit.
In a new licensing deal cut with Swedish Orphan Biovitrum AB (Sobi), ADC Therapeutics SA is getting a $55 million up-front payment and could receive $50 million more upon regulatory approval of Zynlonta (loncastuximab tesirine) in third-line diffuse large B-cell lymphoma by the European Commission.
Nearly a full month ahead of the PDUFA date, ADC Therapeutics SA said Friday the FDA has granted accelerated approval for Zynlonta (loncastuximab tesirine), a CD19-targeted antibody-drug conjugate for the single-agent treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. The approved indication includes the treatment of patients with diffuse large B-cell lymphoma not otherwise specified and those with DLBCL arising from low grade lymphoma and high grade B-cell lymphoma, which ADC's CEO Chris Martin said would be an important point of differentiation for the product.
Sutro Biopharma Inc.’s stock-perking news in early December with STRO-002, a folate receptor alpha-targeting antibody-drug conjugate (ADC) to treat ovarian cancer, reminded investors of potential in the class, which has been more than realized in recent years and could yield more upside in the near term. As of the Oct. 30 cutoff date, STRO-002 tallied one complete response and nine partial responses in the challenging indication, which works out to an overall response rate of 32% (10 out of 31) in evaluable patients.
Coming out of the IPO gate strong was Lausanne, Switzerland-based ADC Therapeutics SA, which priced about 12 million shares at $19 each, for gross proceeds of about $232.7 million in an upsized deal. Shares (NYSE:ADCT) ended the day at $29.65, up $10.65, or 56%.