Erasca Touts ‘Eye-Popping’ ERAS-0015 Lung Cancer Data, FDA Path at BofA Conference

Erasca (NASDAQ:ERAS) executives said the company sees multiple potential development paths for its RAS-targeting portfolio, highlighting early clinical activity for ERAS-0015 in lung, pancreatic and colorectal cancers during a Bank of America biotech conference session.

Jonathan Lim, Erasca’s chairman and chief executive officer, said the company is operating in “a really exciting point in history in targeted therapy,” as drug developers move from KRAS G12C-specific approaches toward broader pan-RAS and pan-KRAS strategies.

Lim said Erasca’s lead pan-RAS molecule, ERAS-0015, has shown differentiated early data, including response rates in non-small cell lung cancer that he described as “eye-popping.” He cited response rates of 62% to 75% in the pharmacologically active dose range of 16 mg to 32 mg in non-small cell lung cancer, depending on the subgroup analyzed.

In the post-checkpoint inhibitor and post-platinum setting, Lim said the company sees a potential monotherapy path in second-line lung cancer, where docetaxel remains a standard treatment option and “there’s ample room for improvement.”

Erasca Plans FDA Discussion After Expansion Data

Lim said Erasca has opened expansion cohorts at recommended doses for expansion of 24 mg and 32 mg and is enrolling non-small cell lung cancer patients at both doses. Once the company has roughly 20 patients in each expansion cohort, he said Erasca plans to package the data and discuss a registrational trial design with the U.S. Food and Drug Administration.

“We do think that an AA path is an open avenue for us,” Lim said, referring to a potential accelerated approval pathway.

The company is also moving ERAS-0015 into combination studies. Lim pointed to Erasca’s clinical trial collaboration and supply agreement with Merck for pembrolizumab, which he called the standard of care in first-line lung cancer. He said Erasca is already enrolling a cohort combining ERAS-0015 with pembrolizumab and plans to identify a combination dose before seeking a first-line non-small cell lung cancer indication.

Lim said Erasca’s formal guidance is to provide an external update in the first half of next year. In the meantime, the company will follow data maturation in lung and pancreatic cancer, including confirmation of responses.

Pancreatic and Colorectal Cancer Remain Key Opportunities

In pancreatic cancer, Lim said Erasca has seen a 41% response rate in the second-line-only setting in China and described U.S. pancreatic data as still maturing. He said some U.S. patients are near the threshold for partial response and could deepen over time.

Lim said first-line pancreatic cancer may be a particularly important opportunity for combinations, especially if ERAS-0015’s tolerability profile allows more complete dosing of both the RAS inhibitor and chemotherapy. He said the first-line pancreatic cancer population represents a larger opportunity than the second-line setting.

In colorectal cancer, Lim highlighted early combinability of ERAS-0015 with panitumumab, an anti-EGFR antibody. He said the company observed a partial response in the first efficacy-evaluable patient on the first scan at the 16 mg dose.

Lim said the anti-EGFR combination may be synergistic rather than merely additive, noting that panitumumab alone would not be expected to produce responses in RAS-driven colorectal cancer. He said response rates around 20% or higher could be meaningful in third-line colorectal cancer, given the high unmet need.

Executives Address Safety Profile and Pneumonitis Case

Lim said Erasca is encouraged by ERAS-0015’s emerging safety and tolerability profile, citing lower observed frequency and severity of rash-related treatment-emergent adverse events, gastrointestinal events such as nausea, vomiting and diarrhea, and stomatitis or mucositis.

David Chacko, Erasca’s chief financial officer and chief business officer, said investigators have qualitatively described the rash profile as better than what they saw with a comparator compound. He said the ability to combine ERAS-0015 with anti-EGFR therapy is an important signal, given that anti-EGFR agents can cause rash on their own.

Chacko also addressed a pneumonitis event that resulted in a patient death. He said the patient had received multiple prior lines of therapy, had lung metastases and had prior cryoablation of the lung, which added complexity to the case. Chacko said the patient ultimately withdrew supportive care, and the principal investigator communicated that the outcome may have been different had supportive care continued.

Chacko said pneumonitis is a known event across multiple oncology drug classes and can be more manageable once physicians know to monitor for it.

Patent Protection and ERAS-4001 Update

Chacko said Erasca received a U.S. composition-of-matter patent for ERAS-0015 extending to 2043. He said the molecule has two structural modifications that have contributed to advantages observed preclinically and clinically, including enhanced CypA binding, improved potency and pharmacokinetic properties.

Erasca is also developing ERAS-4001, a pan-KRAS inhibitor. Chacko said the company expects to report Phase 1 dose-escalation data in the second half of this year, including safety, tolerability, pharmacokinetics and initial signs of activity. He said the dataset can be expected to include “dozens of patients” and will guide monotherapy expansion and combination dose-escalation work in calendar year 2027.

Chacko said pan-KRAS and pan-RAS approaches may ultimately have distinct roles. Pan-KRAS agents could offer tolerability advantages by sparing HRAS and NRAS, while pan-RAS agents may address resistance pathways that emerge when those isoforms are spared, he said.

Capital Allocation Focused on RAS Franchise

Lim said Erasca is prioritizing combinations with standard-of-care therapies in the “big three” tumor types of lung, pancreatic and colorectal cancer, while also monitoring future combination opportunities such as the company’s work with Tango Therapeutics involving PRMT5.

On capital allocation, Lim said Erasca is focused on deploying resources toward core indications and described the company as “singularly focused on the RAS targeting franchise.” He said Erasca remains a “pure play” RAS option for investors.

About Erasca (NASDAQ:ERAS)

Erasca, Inc is a clinical‐stage biopharmaceutical company dedicated to the discovery and development of precision medicines for patients with cancer. The company focuses on small molecule therapeutics that target critical signaling pathways involved in tumor growth and survival, with a primary emphasis on inhibitors of the MAPK pathway. Erasca’s approach is designed to deliver oral, targeted therapies that address both oncogene‐driven and immuno‐oncology indications, aiming to improve outcomes for patients with unmet medical needs.

Erasca’s pipeline comprises multiple development candidates, including small molecule inhibitors engineered to disrupt key nodes in cancer cell signaling.