A Look at ESMO as Companies Share Oncology Updates

The 2020 virtual meeting of the European Society of Medical Oncology is getting underway and companies are lining up to share information on their latest cancer treatments. BioSpace is rounding up a collection of studies that will be shared this week.

Bristol Myers Squibb – More than half of advanced renal cell carcinoma (RCC) patients in the CheckMate-214 study who were treated with a combination of Opdivo (nivolumab) and Yervoy (ipilimumab) were still alive after four years. The study marked the longest follow-up for an immunotherapy-based combination in previously untreated advanced RCC. The sustained survival benefits were observed across the primary patient population, those with intermediate- and poor-risk prognostic factors, and in the intention-to-treat (ITT, i.e. all randomized) patient population, the company said.

The median overall survival was 48.1 months for intermediate- and poor-risk patients treated with the combination therapy. That was in comparison to 26.6 months for Pfizer’s Sutent (sunitinib). The dual immunotherapy combination demonstrated a four-year OS rate of 50%, compared to 35.8% with sunitinib, BMS said. Additionally, the combination of Opdivo and Yervoy demonstrated a higher overall response rate compared to the Pfizer drug. The difference was 65% compared to 50%, BMS said.

The four-year results from CheckMate -214 build on our understanding of and leadership in addressing advanced RCC, reinforcing the potential for durable, long-term survival benefits with Opdivo plus Yervoy in the first-line setting. Taken as a whole, these data provide further evidence for the value of distinct but complementary dual checkpoint inhibition in the treatment of advanced cancers,” Nick Botwood, interim head of BMS’ Oncology Development said in a statement.

NOXXON Pharma – Germany-based NOXXON showed results from a Phase I/II study with a combination of CXCL12 inhibitor, NOX-A12, and pembrolizumab in patients with microsatellite-stable, metastatic colorectal or pancreatic cancer. The enhanced immune response and long survival times for certain late-stage patients combined with the good overall safety profile confirmed in the final data support further development of the combinations treatment and established standard of care regimens in earlier lines of therapy, the company said this morning. The company said the trial showed 25% of the patients in the study experienced disease stabilization. Patients in the study were, on average, receiving a sixth-line of treatment for their disease.

NOX-A12 penetrated cancer tissue in both pancreatic and colorectal cancer patients where it neutralized its target, CXCL12. NOX-A12 monotherapy resulted in induction of a Th1-like immune response in patients when baseline biopsies were compared to post-NOX-A12 monotherapy samples.  The combination of NOX-A12 plus pembrolizumab resulted in stable disease in 25% of patients, and prolonged time on treatment vs. prior therapy for 35% of patients. Overall survival was 39% at 6 months and 20% at 12 months.

“As such, the data from this study provide signals that support a beneficial impact of the combination of NOX-A12 with pembrolizumab for patients with extremely limited options. Thus, we are planning to advance NOX-A12 into the next stage of clinical development in at least one of these indications,” Jarl Ulf Jungnelius, senior medical advisor of NOXXON said in a statement.

Bayer– Bayer presented updated clinical data for Vitrakvi (larotrectinib) that reinforced the consistent, long-term efficacy and established safety profile of the medication in adult and pediatric patients with tropomyosin receptor kinase (TRK) fusion cancer. In addition, new tumor type specific sub-analyses in lung and thyroid cancer patients further emphasize these durable responses with no new safety signals reported, the company said.

Vitrakvi demonstrated a durable overall response rate of 78%, with 19% (n=33) complete responses, 59% partial responses and 13% with stable disease. The ORR in 14 patients with CNS metastases was 71%. After a median follow-up of 13.8 months, the median progression-free survival (PFS) was 36.8 months. Median overall survival was not reached after 15.3 months of follow-up; 12-month estimated median OS rate was 90% and 24-month estimated OS rate was 83%.

Checkpoint Therapeutics – Interim results from a Phase I trial of Checkpoint Therapeutics’ anti-PD-L1 antibody cosibelimab in patients with advanced cancers are showing positive results. Cosibelimab demonstrated a 51.4% objective response rate and 13.5% complete response rate, which is nearly double the complete response rate observed at the time of previous analysis, the company said.

“These exciting new interim results demonstrate the potential best-in-class efficacy and safety profile of cosibelimab. Importantly, the observed ORR and complete response rate in approximately half of the planned pivotal cohort of patients continue to trend higher than the response rates that supported the regulatory approvals of the two currently available anti-PD-1s in mCSCC, which we believe is attributable to cosibelimab’s two-fold mechanism of action of engaging both T-cells and natural killers cells to augment its efficacy. These interim results also continue to demonstrate the potential favorable safety profile of cosibelimab versus available anti-PD-1 therapies, with lower observed rates of severe adverse events,” James F. Oliviero, president and CEO of Checkpoint Therapeutics said in a statement.

Immunicum – France’s Immunicum AB announced preclinical data supporting the combination of ilixadencel, an off-the-shelf, cell-based immune primer, with cancer therapies and immunotherapies including anti-VEGF, anti-PD1 and anti-CTLA4 in a poster presentation at ESMO. Earlier communicated results from preclinical studies in mice demonstrated that animals treated with the combination of ilixadencel and anti-CTLA4 showed a stronger anti-tumor response as compared to animals treated with anti-PD1 and anti-CTLA4, a potent and marketed combination of checkpoint inhibitors. Following the completion of additional experiments, Immunicum observed that ilixadencel, when combined with, anti-VEGF, anti-CTLA4 or anti-CTLA4 and anti-PD1, enabled Complete Responses in a colon carcinoma tumor model (CT26) in mice.

Amunix Pharmaceuticals – Mountain View, Calif.-based Amunix will present preclinical data on two T cell engager programs: AMX-818, the company’s lead clinical candidate which targets HER2, and a second targeting EGFR (EGFR-XPAT) at ESMO. Both programs demonstrate the potential of the company’s XPAT platform to widen the therapeutic index of T cell engagers and overcome the challenge of on-target, off-tumor toxicity that is limiting the use of potent immune activators to treat solid tumors, Amunix said. For its HER2-XPAT clinical candidate, AMX-818, the company has initiated IND-enabling studies.