Seven Companies Present Exciting News at ESMO 2021
Biopharma companies big and small are presenting exciting clinical studies at the European Society for Medical Oncology Congress 2021. Here’s a look at just some of those highlights.
Amgen announced the first combination study results from the Phase Ib/II CodeBreaK 101 trial. The data demonstrated that combining Lumakras (sotorasib) with Vectibix (panitumumab), Amgen’s monoclonal antibody EGFR inhibitor, demonstrated encouraging efficacy and safety in KRAS G12C-mutated advanced colorectal cancer (CRC). The ORR was 27% among 26 patients in the efficacy analysis, while disease control rate (DCR) was 81%. In the expansion cohort of patients who had not received sotorasib with refractory CRC, 33% had a response.
“We are excited by these CodeBreaK 101 data, which show encouraging response rates that were much higher than the 9.7% response rate observed with Lumakras monotherapy and highlight the importance of combination therapy for patients with KRAS G12C-mutated advanced colorectal cancer,” said Amgen Executive Vice President, Research and Development David M. Reese.
Merck presented new Phase III results from several studies of its checkpoint inhibitor Keytruda (pembrolizumab), including KEYNOTE-716 in melanoma, KEYNOTE-826 in recurrent, persistent or metastatic cervical cancer, and KEYNOTE-355 in metastatic triple-negative breast cancer. It also presented data on Lynparza (Olaparib, in collaboration with AstraZeneca) in ovarian cancer, and Lenvima (Lenvatinib, in collaboration with Eisai) in endometrial carcinoma and renal carcinoma. It also presented data for Welireg (belzutifan).
“Merck has made significant progress in demonstrating the impact our medicines can have on people living with certain cancers, especially with those with hard-to-treat, metastatic disease,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We continue to build on this knowledge as we advance important scientific research evaluating our medicines in early stages of disease, and in combination with other treatments, to help improve patient outcomes.”
Novartis announced positive health-related quality of life (HRQoL) data form its Phase III VISION trial of 177Lu-PSMA-617 for metastatic castration-resistant prostate cancer (mCRPC) compared to standard of care alone. 177Lu-PSMA-617 is an investigational targeted radioligand therapy. HRQoL demonstrated delayed worsening of symptoms. The company also presented more than 55 abstracts from Novartis-sponsored and investigator-initiated trials across its portfolio and pipeline. They included overall survival (OS) data form the Phase III MONALEESA-2 study of postmenopausal patients with HR+/HER2- advanced breast cancer with endocrine therapy plus or minus Kisqali (ribociclib).
Susanne Schaffert, President, Novartis Oncology, said, “With deeper analyses in overall survival and quality of life in breast and prostate cancer, as well as exciting research in other solid tumors, our data at ESMO demonstrates our ambition to transform lives and renew patients’ hope for the future.”
Aileron Therapeutics presented new clinical data supporting ALRN-6924’s best-in-class potential as a chemoprotective agent; that is to say, it reduces neutropenia, thrombocytopenia and anemia caused by chemotherapy, and also decreases the need for blood transfusions. Aileron presented final results from the completed Phase Ib trial in small cell lung cancer (SCLC) patients receiving second-line topotecan; the company also presented preliminary results from the ongoing Phase I trial in healthy volunteers, which confirmed the drug’s optimal dose, its mechanism of action, and time to onset, duration and magnitude of its pharmacodynamic effects.
“The data presented at ESMO further strengthen our belief in ALRN-6924’s best-in-class potential in the emerging chemoprotection space,” said Manuel Aivado, president and chief executive officer of Aileron. “With our precision medicine strategy, our vision is to bring the first selective chemoprotective agent to all patients with p53-mutated cancer while ensuring no interruption of chemotherapy.”
Oncxerna Therapeutics announced new clinical and biomarker data from its bavituximab program of ONCG100, an open-label phase II clinical trial of bavituximab combined with Merck’s Keytruda in advanced gastric or gastroesophageal junction (GEJ) cancer. Bavituximab is a potential first-in-class phosphatidylserine (PS) inhibitor designed to reverse immune suppression. Patients in the trial underwent pre-treatment biopsies to allow for pre-specified biomarker analysis via the Xerna TME Panel.
“Predictive biomarkers are an urgent need in gastric cancer where treatment options are limited and only a small fraction of patients’ treatment is biomarker-driven,” said Ian Chau, consultant medical oncologist at the Royal Marsden Hospital. “This study used OncXerna’s novel RNA expression-based algorithm to classify the biology of the tumor microenvironment of individual gastric cancer patients and prospectively tested the hypothesis that patient tumors classified as having a high immune score by the Xerna TME Panel are more likely to benefit from treatment with bavituximab in combination with pembrolizumab [Keytruda]. The results support this hypothesis by showing that the Xerna TME Panel biomarker was predictive of improved treatment response rates.”
BeyondSpring Pharmaceuticals announced new positive data on plinabulin from its chemotherapy-induced neutropenia (CIN) prevention program. The drug, in combination with G-CSF for the prevention of CIN, is being reviewed in the U.S. with a PDUFA date of November 30, 2021. It is also under review by Chinese regulators. The company presented three posters at ESMO.
“We’re pleased to present additional positive data at this year’s ESMO Congress to show that the Grade 4 neutropenia endpoint is correlated with clinically meaningful endpoints in a meta-analysis with >7000 patients in various cancer and various chemotherapy,” said Ramon Mohanlal, executive vice president, R&D, and chief medical officer at BeyondSpring. “This adds to our existing body of data in CIN prevention, a critically important indication for cancer patients.”
Nouscom announced initial results from the Phase I trial of NOUS-209 in Microsatellite Instable High (MSKI-H) gastric, colorectal and gastro-esophageal junction solid tumors. The drug, an off-the-shelf cancer vaccine based on shared neoantigens, was dosed with Merck’s Keytruda, and showed promising early signs of clinical efficacy with no dose-limiting toxicities.
“There is still a significant unmet need in the treatment of MSI-H tumors, with many patients not responding to a single agent immunotherapy,” said Michael Overman, principal investigator of the trial and professor in the Department of Gastrointestinal Medicine at the University of Texas MD Anderson Cancer Center. “The technology developed by Nouscom is innovative and looks to address this issue — the Phase I results are very encouraging, and this data provides exciting early validation of the multi-neoantigen approach in humans, supporting the compelling preclinical data seen previously.”
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