Benzinga | Jan 11, 2022 07:10AM EST

Verastem Oncology Outlines 2022 Priorities And Upcoming Catalysts

Report Selection Phase (Part A) Results from RAMP 201 and RAMP 202 Evaluating VS-6766 Alone and in Combination with Defactinib in Low-Grade Serous Ovarian Cancer (LGSOC) and KRAS-Mutant Non-Small Cell Lung Cancer (NSCLC), Respectively

Report Preliminary Data from Phase 1/2 Trial Evaluating LUMAKRAS(tm) (sotorasib) and VS-6766 and Initiate Phase 1/2 Trial Evaluating adagrasib and VS-6766; Both in KRAS G12C-Mutant Non-Small Cell Lung Cancer

Expand Ongoing Investigator-Initiated Trial Program to Explore Combination Potential with VS-6766 in Additional Areas of High Unmet Need; Data Read-Outs Expected Throughout 2022

Verastem Oncology (NASDAQ:VSTM), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, today outlined key strategic priorities and upcoming catalysts to support its lead compound VS-6766 in 2022. VS-6766 is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF, potentially creating a more complete and durable anti-tumor response through maximal RAS pathway inhibition. VS-6766 is currently in late-stage development.

"Building on the Breakthrough Therapy designation for VS-6766 with defactinib in recurrent low-grade serous ovarian cancer, the significant progress of our RAMP program in both low-grade serous ovarian cancer and KRAS G12V-mutant non-small cell lung cancer, our clinical collaborations in KRAS G12C-mutant non-small cell lung cancer as well as our ongoing investigator-initiated trials program, we expect to see tremendous progress on behalf of patients in 2022," said Brian Stuglik, CEO of Verastem Oncology. "We plan to efficiently advance our development strategy, report multiple data readouts and further highlight the differentiated potential of VS-6766 across tumor types and mutations."

2022 Strategic Priorities

Gynecologic Oncology Program

* Fully enroll Part B of the RAMP 201 trial (LGSOC VS-6766 +/- defactinib).

* Expand development program into other RAS pathway-driven gynecologic cancers.

Non-Small Cell Lung Cancer (NSCLC) Program

* Select regimen for Part B of the RAMP 202 trial (KRAS G12V NSCLC VS-6766 +/- defactinib).

* Initiate and complete dose-finding portions of RAMP 203 (KRAS G12C NSCLC VS-6766 + LUMAKRASTM (sotorasib)) and RAMP 204 (KRAS G12C NSCLC VS-6766 + adagrasib) combination trials.

* Provide signal read-out of investigator-sponsored trial of VS-6766 and everolimus in KRAS- mutant NSCLC.

Other Programs

* Expand investigator-initiated trial program to include signal-finding studies in other tumor types, including melanoma, breast and colorectal cancers.

* Expand clinical combinations with VS-6766.

Anticipated 2022 Development Milestones and Catalysts

1Q-2022

* Having completed target enrollment (n=64) in the selection phase (Part A) of the Phase 2 RAMP 201 trial (LGSOC VS-6766 +/- defactinib), the enrollment phase (Part B) is now ongoing with both treatment arms currently advancing.

* Complete enrollment in the selection phase (Part A) of the Phase 2 RAMP 202 trial (KRAS G12V NSCLC VS-6766 +/- defactinib).

* Initiate RAMP 203 trial (KRAS G12C NSCLC VS-6766 + LUMAKRASTM (sotorasib)) with Amgen.

Q2-2022

* Report topline results from Part A of the RAMP 201 trial (LGSOC VS-6766 +/- defactinib), following discussions with regulatory authorities.

* Initiate RAMP 204 trial (KRAS G12C VS-6766 + adagrasib) with Mirati.

* Present topline results of investigator-initiated trial of VS-6766 and everolimus in KRAS-mutant NSCLC.

* Present investigator-initiated FRAME LGSOC translational data.

2H-2022

* Complete enrollment in the RAMP 201 trial (LGSOC VS-6766 +/- defactinib).

* Report topline results from RAMP 202 trial (KRAS G12V NSCLC VS-6766 +/- defactinib) and initiate the expansion phase (Part B), following discussions with regulatory authorities.

* Report initial readout of the RAMP 203 trial (KRAS G12C NSCLC VS-6766 + LUMAKRASTM (sotorasib)) with Amgen.

"We are pleased with the progress of our scientific collaborations and the high level of interest of leading investigators to advance the preclinical synergy data towards clinical evaluation of VS-6766 in combinations across multiple tumor types, including melanoma, colorectal and breast cancers," said Louis Denis, CMO of Verastem Oncology. "These clinical research efforts complement our company-sponsored development program and help to expediently advance our efforts to address an even broader scope of significant unmet medical needs."