Affimed announced that three abstracts of clinical trial designs of its AFM24 innate cell engager have been published and will be presented at the ASCO Annual Meeting on June 3-7. The Trial in Progress posters provide background information and introduce the study designs of the three ongoing AFM24 studies in which patients with a variety of EGFR-positive solid tumors are treated with AFM24 monotherapy or in combinations with either Roche's checkpoint inhibitor, atezolizumab, or NKGen Biotech's autologous NK cell product, SNK01. The AFM24 monotherapy study abstract includes information about the dose-escalation phase of the study. An ongoing phase 1/2a, first-in-human study is evaluating AFM24 in patients with locally advanced or metastatic, treatment refractory solid tumors that are known to express EGFR. AFM24 had a well-managed safety profile and the RP2D was established at 480 mg. In parallel to the continuing dose escalation phase, a phase 2a dose expansion study was initiated, and the first patient was enrolled in January 2022. The trial will progress to the second stage unless the null hypothesis, that the true tumor response rate is below a specific value, is confirmed at the end of stage one. The AFM24 combination with atezolizumab study abstract details the trial design and rationale for the combination study of AFM24 and atezolizumab in patients with advanced EGFR-expressing solid tumors. An ongoing phase 1/2a open-label, non-randomized, multicenter, dose escalation and dose expansion study was initiated in November 2021 to evaluate the safety, tolerability and efficacy of AFM24 in combination with atezolizumab. The primary aim of the phase 1 study is to determine the maximum tolerated dose and the RP2D of AFM24. Escalating doses of AFM24 will be given to each cohort as weekly intravenous infusions. The phase 2a study will establish the overall response rate and safety of the combination therapy in patients with various types of cancer.

Puma Biotechnology announced the publication of two abstracts on neratinib to be presented at the 2022 ASCO Annual Meeting. The full posters will be available on the Puma website following the presentations. The first abstract's title is: Targeting HER2 mutation-positive advanced biliary tract cancers with neratinib: final results from the phase 2 SUMMIT 'basket' trial. The second abstract is titled "Neratinib plus fulvestrant plus trastuzumab (N+F+T) for hormone receptor-positive (HR+), HER2-negative, HER2-mutant metastatic breast cancer (MBC): Outcomes and biomarker analysis from the SUMMIT trial".

Arbutus Biopharma's abstract on a preclinical oncology study for one of Arbutus' oral PD-L1 inhibitor compounds, designed to reawaken the immune system, has been selected for publication at the ASCO Annual Meeting. The abstract's title is "Pre-clinical anti-tumor activity of small-molecule oral PD-L1 checkpoint inhibitors". Immune checkpoints such as PD-1/PD-L1 play an important role in the induction and maintenance of immune tolerance and in T-cell activation.

PDS Biotechnology "announced an upcoming poster presentation of preliminary data from its ongoing Phase 2 VERSATILE-002 clinical trial at the American Society of Clinical Oncology, ASCO, Annual Meeting taking place June 3-7, 2022 in Chicago and online. VERSATILE-002 is a single-arm Phase 2 study evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech's proprietary Versamune technology, in combination with Merck's anti-PD-1 therapy KEYTRUDA. The combination is being evaluated in checkpoint inhibitor-naive and CPI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma. The data being presented at ASCO will detail preliminary safety and efficacy data for CPI-naive patients at a prespecified interim analysis point. In the VERSATILE-002 clinical trial, patients are being treated with KEYTRUDA(R) 200 mg by IV infusion every three weeks, plus subcutaneous injection of PDS0101 for the first 4 treatment cycles and again on Cycle 12; KEYTRUDA treatment continues for up to 35 cycles, or until disease progression or demonstrated intolerance to therapy."

SpringWorks Therapeutics (SWTX) "announced initial clinical data from the Phase 1/2 study evaluating nirogacestat, SpringWorks' investigational gamma secretase inhibitor, in combination with BLENREP, GSK plc's (GSK) antibody drug conjugate targeting B-cell maturation agent, in patients with relapsed or refractory multiple myeloma. In addition, SpringWorks also highlighted long-term follow-up data from a Phase 2 study sponsored by the National Cancer Institute evaluating nirogacestat in patients with progressing desmoid tumors, which included follow-up on progression-free survival and long-term safety data.2 These data sets will be shared in poster sessions at the 2022 American Society of Clinical Oncology Annual Meeting, June 3-7, 2022 in Chicago. The objective of this sub-study of GSK's DREAMM-5 platform trial is to determine if low-dose BLENREP in combination with nirogacestat results in similar efficacy with an improved ocular toxicity profile compared to single-agent BLENREP at its approved dose and schedule. The study opened with a dose-exploration arm evaluating 0.95 mg/kg BLENREP Q3W combined with 100 mg BID nirogacestat dosed continuously, and subsequently moved into a cohort expansion arm. The target enrollment for the CE arm of the study is 70 patients randomized either to BLENREP 2.5mg/kg Q3W monotherapy or low-dose BLENREP plus nirogacestat combination using the same dose as the DE arm cohort. The study enrolled patients with relapsed or refractory multiple myeloma who have received at least 3 prior lines of therapy, including an immunomodulatory agent, proteasome inhibitor, and anti-CD38 antibody. The poster being presented at ASCO includes data from a total of 24 patients treated with low-dose BLENREP + nirogacestat across the DE and CE cohorts and 14 patients treated with monotherapy BLENREP in the CE cohort. At the time of the March 4, 2022 data cut-off, the median of follow-up in the low-dose BLENREP plus nirogacestat DE cohort was 34.5 weeks (5-88 weeks), with durations of response exceeding one year in some patients. Data from the CE cohorts are not yet mature with a median duration of follow-up of 12 weeks available at the time of data cut-off. The CE cohorts utilized the KVA ocular toxicity grading scale; Grade 3 ocular adverse events occurred in 1/14 patients in the low-dose BLENREP plus nirogacestat combination compared to 7/14 patients in the BLENREP monotherapy arm. The DE cohort utilized the CTCAE-5 ocular toxicity grading scale; the low-dose BLENREP plus nirogacestat combination demonstrated Grade 3 ocular adverse events in 2/10 patients. At the time of data cut-off, the objective response rate of low-dose BLENREP plus nirogacestat across the DE and CE cohorts was 38%, with 17% of patients achieving a VGPR or better. The ORR of the BLENREP monotherapy control arm was 50%, with no patients achieving a VGPR or better."