In a Phase 3 clinical trial, the addition of sugemalimab to chemotherapy improved median overall survival by 8.5 months versus placebo plus chemotherapy in people with previously untreated Stage IV non-small cell lung cancer (NSCLC)
In a Phase 2 trial, sugemalimab treatment resulted in durable responses in people with relapsed or refractory extranodal natural killer/T-cell lymphoma, with approximately half of patients achieving a response and approximately one third achieving a complete response
In a Phase 3 trial, aumolertinib reduced the risk of central nervous system disease progression in people with advanced EGFR-mutated NSCLC by 68% compared to gefitinib
CAMBRIDGE, Mass., May 26, 2022 (GLOBE NEWSWIRE) -- EQRx, Inc. (Nasdaq: EQRX), a new type of pharmaceutical company committed to developing and delivering innovative medicines to patients at radically lower prices, today announced data from pivotal trials of sugemalimab, a PD-L1 inhibitor, and aumolertinib, a third-generation EGFR-tyrosine kinase inhibitor (TKI), being presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting taking place from June 3 through June 7, 2022. The data further demonstrate the potential clinical benefit of these investigational medicines in non-small cell lung cancer (NSCLC) and of sugemalimab in relapsed or refractory (R/R) extranodal natural killer/T-cell lymphoma (ENKTL), a rare and aggressive form of non-Hodgkin lymphoma (NHL) that does not have approved treatment options in the U.S. These data will help support global regulatory submissions for sugemalimab and aumolertinib.
“These new data add to the growing body of evidence pointing to the clinical benefit of our two lead oncology programs, aumolertinib and sugemalimab, further affirming our confidence in their potential to become important future treatment options,” said Vince Miller, MD, physician-in-chief at EQRx. “EGFR inhibitors and PD-L1 immunotherapies have been ground-breaking therapeutic classes in treating non-small cell lung cancer and other types of cancer, but also among the most expensive. We are committed to advancing aumolertinib and sugemalimab through global regulatory pathways to expand access to these impactful classes of medicine – an imperative in making more equitable cancer care a reality.”
GEMSTONE-302 Study in Stage IV NSCLC
The majority of the 1.6 million people diagnosed with NSCLC each year worldwide are found to have Stage IV disease.1 Prognosis for these patients is poor, with a five-year survival rate of 8%.2 There is a need for safe, effective and accessible therapeutic options for people with this form of cancer worldwide.
The pre-specified interim analysis of overall survival (OS) from the randomized, double-blind Phase 3 GEMSTONE-302 (NCT03789604) study in patients with previously untreated Stage IV NSCLC demonstrated sugemalimab plus platinum-based chemotherapy reduced the risk of death by 35% compared to platinum-based chemotherapy plus placebo; median OS was 25.4 months for the sugemalimab plus chemotherapy arm versus 16.9 months for the placebo plus chemotherapy arm (hazard ratio [HR]=0.65; 95% CI, 0.50-0.84; P=0.0008). Two-year OS rates were 51.7% for the sugemalimab plus chemotherapy arm and 35.6% for the placebo plus chemotherapy arm.
OS benefit was observed in the sugemalimab plus chemotherapy group compared with the placebo plus chemotherapy group across all subgroups, including those with squamous (median OS 23.3 vs. 12.2 months; HR=0.56) and non-squamous NSCLC (median OS 26.9 vs. 19.8 months; HR=0.72) as well as in patients with different levels of PD-L1 expression (PD-L1 ≥1%, median OS 27.0 vs. 19.0 months, HR=0.64; PD-L1 <1%, median OS 19.4 vs. 14.8 months, HR=0.66). The safety profile for sugemalimab plus chemotherapy was consistent with that reported previously and no new safety signals were identified with longer follow-up.
These results will be featured in a poster presentation on Monday, June 6 at 9:00 a.m. ET (abstract #9027, Lung Cancer—Non-small Cell Metastatic session).*
GEMSTONE-201 study in R/R ENKTL
In the U.S., there are currently no therapies approved specifically for the treatment of R/R ENKTL, a rare and aggressive form of NHL.
Data are being presented for the first time from the primary analysis of the single-arm, multicenter, Phase 2 GEMSTONE-201 (NCT03595657) study in people with R/R ENKTL. The objective response rate for patients treated with sugemalimab was 46.2%, with 37.2% of patients achieving a complete response. The one-year duration of response rate was 86% and the median duration of response was not reached as of the cutoff date. Sugemalimab had a manageable safety profile, and no new safety signals were observed compared to the known safety profile of sugemalimab in other cancer types.
Longer follow-up data now available from this study confirm these findings.3
The GEMSTONE-201 data will be presented in an Oral Abstract Session on Friday, June 3 at 2:12 p.m. ET (abstract #7501, Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia session).*
AENEAS Study in EGFR-mutated NSCLC
Approximately 15 to 20% of people with NSCLC have brain metastases at diagnosis, and as many as 40% will eventually develop brain metastases during their illness.4,5,6 For those who have brain metastases, prognosis is poorer than for those who do not, making efficacy against central nervous system (CNS) metastases desirable for therapeutics that treat NSCLC. 7
New data from the Phase 3 AENEAS (NCT03849768) study demonstrated that aumolertinib reduced the risk of CNS progression as a first-line treatment in patients with locally advanced or metastatic EGFR-mutated NSCLC who had baseline CNS metastases by 68% compared to gefitinib (29.0 vs 8.3 months; HR=0.319; 95% CI, 0.176-0.580; P<0.0001). In patients who had baseline CNS target lesions, the median progression-free survival (PFS) was 29.0 months for aumolertinib vs. 8.3 months for gefitinib (HR=0.268; 95% CI, 0.119-0.605; P=0.0007). The safety profile for aumolertinib was consistent with that reported previously and no new safety signals were observed.
This presentation builds on the recent publication of earlier data from AENEAS in Journal of Clinical Oncology, which showed treatment with aumolertinib resulted in a clinically significant improvement in PFS compared to gefitinib in first-line treatment of patients with locally advanced or metastatic NSCLC with the most common types of EGFR mutations.
These results will be featured in a poster presentation on Monday, June 6 at 9:00 a.m. ET (abstract #9096, Lung Cancer—Non-small Cell Metastatic session).**
About Non-small Cell Lung Cancer (NSCLC)
Lung cancer is the leading cause of cancer death for men and women worldwide.8 Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 85% of all lung cancer diagnoses, and globally about one-third of patients have EGFR mutations.9 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.10 Treatment options for NSCLC include surgery, radiation therapy, chemotherapy, targeted therapy and immunotherapy.11
About Extranodal Natural Killer/T-cell Lymphoma (ENKTL)
Extranodal natural killer/T-cell lymphoma (ENKTL) is a rare, aggressive form of non-Hodgkin lymphoma (NHL) that arises outside the lymph nodes, most commonly in the nose.12,13 The incidence of ENKTL varies by geographic region: in the US, ENKTL occurs in about 0.2 to 0.4% of NHL cases, whereas it is more common in Asia and in Central and South America.14 The prognosis of relapsed or refractory ENKTL is poor, and there are currently no approved treatments for the disease in the U.S.15
About the GEMSTONE-302 Trial
GEMSTONE-302 (NCT03789604) is a randomized, double-blind, Phase 3 study designed to evaluate the efficacy and safety of sugemalimab versus placebo in combination with carboplatin-based chemotherapy as a first-line treatment for patients with Stage IV squamous or non-squamous non-small cell lung cancer (NSCLC). The study was conducted by CStone Pharmaceuticals and included 479 patients who were randomized to either the sugemalimab group (n=320) or the placebo group (n=159). The study met its primary endpoint, demonstrating significant improvement in investigator-assessed progression-free survival (PFS) with sugemalimab plus chemotherapy compared to placebo plus chemotherapy.16 Secondary endpoints include overall survival, PFS in patients with PD-L1 ≥1% (assessed by the investigators), overall response rate (assessed by the investigators), PFS assessed by blinded independent central review (BICR), duration of response and safety.
About the GEMSTONE-201 Trial
GEMSTONE-201 (NCT03595657) is a single-arm, multicenter, Phase 2 pivotal study designed to evaluate the efficacy and safety of sugemalimab as monotherapy for the treatment of adults with relapsed or refractory extranodal natural killer/T-cell lymphoma (ENKTL). The study was conducted by CStone Pharmaceuticals and enrolled 80 patients. The study met its primary endpoint of objective response rate (ORR) as assessed by independent radiological review committee according to Lugano 2014 classification. Secondary endpoints include investigator-assessed ORR, duration of response, time to response and safety.
About the AENEAS Trial
AENEAS (NCT03849768) is a randomized, double-blind, multicenter, Phase 3 study designed to evaluate the efficacy and safety of aumolertinib versus gefitinib as first-line treatment for adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). The study was conducted by Hansoh Pharmaceuticals and enrolled 429 patients, who were randomized to receive either aumolertinib (n=214) or gefitinib (n=215). The study met its primary endpoint, demonstrating clinically significant improvement in progression-free survival as compared to gefitinib according to Response Evaluation Criteria in Solid Tumors version 1.1.17 Secondary endpoints include overall survival, overall response rate and safety.
Sugemalimab is a monoclonal antibody targeting programmed death-ligand 1 (PD-L1) that is currently being investigated in several ongoing clinical trials, including studies in relapsed or refractory extranodal natural killer/T cell lymphoma (ENKTL), Stage III non-small cell lung cancer (NSCLC), Stage IV NSCLC, gastric cancer and esophageal cancer. In October of 2020, the U.S. Food and Drug Administration (FDA) granted sugemalimab Breakthrough Therapy designation for the treatment of adult patients with relapsed or refractory ENKTL. Sugemalimab in combination with chemotherapy is approved by the National Medical Products Administration (NMPA) of China for the first-line treatment of patients with metastatic squamous and non-squamous NSCLC. EQRx has partnered with CStone Pharmaceuticals on global development of sugemalimab with the goal of expanding access worldwide. EQRx holds the development and commercialization rights to sugemalimab outside of Greater China.
Aumolertinib is a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets both EGFR-sensitizing and T790M resistance mutations, with high selectivity over wild-type EGFR.18 Aumolertinib is being investigated in several ongoing clinical trials, including studies in first- and second-line EGFR-mutated non-small cell lung cancer (NSCLC). Aumolertinib is approved by the National Medical Products Administration (NMPA) of China for
first-line and second-line treatment of patients with locally advanced or metastatic EGFR mutation-positive NSCLC. Aumolertinib was discovered by Hansoh Pharmaceuticals, and EQRx has partnered with Hansoh Pharmaceuticals on global development of aumolertinib with the goal of expanding access worldwide. EQRx holds the development and commercialization rights to aumolertinib outside of Greater China.
EQRx is a new type of pharmaceutical company committed to developing and delivering innovative medicines to patients at radically lower prices. Launched in January 2020, EQRx is purpose-built, at scale, with a growing catalog of medicines in development in high-cost drug categories and emerging partnerships with leading payers and providers. Leveraging cutting-edge science and technology and strategic partnerships with stakeholders from across the healthcare system, EQRx aims to provide innovative, patent-protected medicines more efficiently and cost-effectively than ever before. To learn more, visit www.eqrx.com and follow us on social media: Twitter: @EQRxInc, LinkedIn, Instagram: @eqrxinc.
EQRx™ and Remaking Medicine™ are trademarks of EQRx.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements may be identified by the use of words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “design,” “strategy,” “future,” “opportunity,” “continue, “aim,” “goal,” “plan,” “may,” “look forward,” “should,” “will,” “would,” “will be,” “will likely result,” and similar expressions. These forward-looking statements include, but are not limited to, express or implied statements regarding presentation of data for EQRx’s product candidates; timing of regulatory submissions; development of EQRx’s catalog of medicines; EQRx’s plans for clinical trials; and EQRx’s ability to develop and deliver innovative medicines at radically lower prices and to create a new pharma platform that both improves patients’ health and delivers meaningful savings. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to the inherent risks in pharmaceutical development, including with respect to the conduct of clinical trials and risk of delays; risks that the results of prior clinical trials may not be predictive of future results; risks regarding the timing and outcome of EQRx’s interactions with regulatory authorities; risks that the regulatory pathway in one or more markets may not be compatible with EQRx’s business model; risks associated with successfully demonstrating the safety, efficacy and tolerability of its drug candidates and obtaining regulatory approvals therefor; expectations regarding EQRx’s existing collaborations with CStone Pharmaceuticals and Hansoh Pharmaceuticals and its other existing and future collaboration partners; risks associated with EQRx’s ability to otherwise implement its business plans changes in the competitive and highly regulated industries in which EQRx operates, including laws and regulations affecting EQRx’s business; and other risks associated with its plans to create a new kind of pharmaceutical company, among others. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section in EQRx’s most recent Annual Report on Form 10-K as well as any other filings with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and EQRx assumes no obligation, and does not intend, to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.
Investors and others should note that we communicate with our investors and the public using our website www.eqrx.com, including, but not limited to, company disclosures, investor presentations and FAQs, SEC filings, press releases, public conference call transcripts and webcast transcripts. The information that we post on our website could be deemed to be material information. As a result, we encourage investors, the media and other interested parties to review the information that we post there on a regular basis. The contents of our website shall not be deemed incorporated by reference in any filing with the SEC.
* EQRx and CStone Pharmaceuticals have partnered on the global development of sugemalimab. This presentation will be shared by CStone Pharmaceuticals and its collaborators.
** EQRx and Hansoh Pharmaceuticals have partnered on the global development of aumolertinib. This presentation will be shared by Hansoh Pharmaceuticals and its collaborators.
1 Guo H, et al. Front Oncol. 2021;11:761042. doi: 10.3389/fonc.2021.761042
2 American Cancer Society. “Lung Cancer Survival Rates.” Accessed May 4 2022. Available at: https://www.cancer.org/cancer/lung-cancer/detection-diagnosis-staging/survival-rates.html.
3 EQRx data on file.
4 Kim SY, et al. J Korean Med. Sci 20:121-126, 2005. Doi: 10.3346/jkms.2005.20.1.121
5 Hochstenbag MMH, et al: Lung Cancer Amst Neth. 42:189-193, 2003. doi: 10.1016/s0169-5002(03)00291-5
6 Moro-Sibilot D, et al. Lung Cancer. 90:427-432, 2015. doi: 10.1016/j.lungcan.2015.11.011
7 Ali A, et al. Curr Oncol. 2013:20(4): e300-e306. doi: 10.3747/co.20.1481
8 Sung H, et al. CA Cancer J Clin. 2021;71(3):209-249. doi: 10.3322/caac.21660
9 Zhang Y-L, et al. Oncotarget. 2016;7(48):78985–78993. doi: 10.18632/oncotarget.12587
10 American Cancer Society. ”What is Lung Cancer?” Accessed May 3, 2022. Available at: https://www.cancer.org/cancer/lung-cancer/about/what-is.html.
11 American Cancer Society. “Treating Non-Small Cell Lung Cancer.” Accessed May 4 2022. Available at: https://www.cancer.org/cancer/lung-cancer/treating-non-small-cell.html
12 Lymphoma Action. “Extranodal NK/T-cell lymphoma, nasal type.” Accessed May 5, 2022. Available at: https://lymphoma-action.org.uk/types-lymphoma-non-hodgkin-lymphoma-t-cell-lymphomas/extranodal-nkt-cell-lymphoma-nasal-type
13 Wang H, et al. Leukemia. 2021;35:2460–2468 (2021). doi: 10.1038/s41375-021-01313-2.
14 van Doesum JA, et al. Hemasphere. 2021;(2): e523. doi: 10.1097/HS9.0000000000000523
15 Allen PB and Lechowicz MJ. J Oncol Pract. 2019;15(10):513–520. doi: 10.1200/JOP.18.00719
16 Zhou C, et al. The Lancet Oncology. 2022;23(2):220-223. doi: https://doi.org/10.1016/S1470-2045(21)00650-1
17 Lu S, et al. Journal of Clinical Oncology. 2022. doi: 10.1200/JCO.21.02641
18 Lu S, et al. J Thorac Oncol. 2022;17(3):411-422. doi: 10.1016/j.jtho.2021.10.024