Full Press Release Details
Zai Lab Announces Second Quarter 2022
Financial Results and Corporate Updates
-Key pipeline milestones achieved including the BLA acceptance of efgartigimod by China's NMPA and positive topline results for the KarXT Phase 3 EMERGENT-2 trial
-Continued revenue growth led by ZEJULA strong balance sheet with a cash position of $1.26 billion
-Company to host a conference call and webcast on August 10, 2022, at 8 00 a.m. ET
SHANGHAI, SAN FRANCISCO, and CAMBRIDGE, Mass., August 9, 2022 -- Zai Lab Limited (NASDAQ ZLAB HKEX 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced financial results for the second quarter of 2022, along with recent product highlights and corporate updates.
"We executed well in the second quarter and delivered strong results," said Dr. Samantha Du, Founder, Chairperson and CEO, of Zai Lab. "Despite the challenging operating environment, Zai has continued to achieve all of our corporate priorities, including the BLA acceptance for efgartigimod by China's NMPA. With the positive topline readout from the Phase 3 EMERGENT-2 trial in schizophrenia earlier this week, we believe KarXT could be a very important treatment option as the first new class of medicine in over half a century for the many patients suffering from schizophrenia in China and globally. I'm also excited that our pipeline continues to mature and demonstrate first and best-in-class potential. In addition, there were positive data readouts for adagrasib, CLN-081, repotrectinib, efgartigimod, ZEJULA and Tumor Treating Fields in the second quarter. Importantly, our commercial operations remain resilient in the face of the ongoing pandemic situation in certain regions in China. For the remainder of the year, we are on track to deliver our remaining 2022 corporate priorities, including an NDA submission to the NMPA for sulbactam-durlobactam, advancing ZL-1102 (anti-IL-17A Humabody ) into full global development, as well as seeking NRDL inclusion for QINLOCK and NUZYRA. We are also very pleased to welcome Josh Smiley as our COO at this exciting time given his operational expertise, global experience, and deep understanding of Zai Lab and our industry."
"I am thrilled to be joining Zai Lab at such a pivotal time in the company's history," said Josh Smiley, COO of Zai Lab. "Zai is working toward becoming a leading global biotech company, leveraging its commercial success in Asia and its development of global products. The advancement of Zai's proprietary research pipeline and the diversification of its portfolio beyond its traditional strength in oncology present tremendous opportunities. I am looking forward to working with the great team and helping scale the company both in China and in the United States."
Recent Product Highlights and Anticipated Milestones
ZEJULA is an oral, once-daily small-molecule poly (ADP-ribose) polymerase (PARP) 1 2 inhibitor. It is the only PARP inhibitor approved in the United States, the European Union, and mainland China (hereinafter, "China") as a monotherapy for patients with advanced ovarian cancer, regardless of their biomarker status.
Recent Product Highlight
In June 2022, Zai Lab presented a new prespecified subgroup analysis from the Phase 3 PRIME study for niraparib in patients in China with ovarian cancer at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. This analysis examined 384 newly diagnosed stage III or IV ovarian cancer patients enrolled in the PRIME study who experienced a complete response (CR) or partial response (PR) to first-line platinum-based chemotherapy.
-In the CR group The median progression-free survival (mPFS) was 29.4 months for niraparib vs 8.3 months for placebo (HR 0.45 95% confidence interval CI , 0.32-0.61 P 0.001).
-In the PR group The mPFS was 19.3 months for niraparib versus 8.3 months for placebo (HR 0.45 95% CI, 0.23-0.86 P 0.014).
-The safety profile of niraparib was consistent with previous clinical trials, with no new safety issues identified in this subgroup analysis.
Tumor Treating Fields
Tumor Treating Fields (TTFields) are electric fields that disrupt cancer cell division. Optune and Optune Lua, commercial TTFields devices, are approved or marketed in certain countries or regions for the treatment of newly diagnosed and recurrent glioblastoma and malignant pleural mesothelioma.
Recent Product Highlights
In June 2022, Zai Lab and Novocure announced the EF-31 phase 2 pilot study, evaluating the safety and efficacy of TTFields together with standard-of-care (chemotherapy alone or in combination with trastuzumab for HER2-positive patients) as a first-line treatment in patients with gastric cancer, met its primary endpoint of objective response rate (ORR) with supportive signals across secondary endpoints.
As of June 30, 2022, Optune has been listed in 50 regional customized commercial health insurance plans guided by provincial or municipal governments (or "supplemental insurance plans").
Anticipated 2022 Partner and Zai Milestone
Last patient enrollment anticipated in the Phase 3 pivotal METIS clinical trial evaluating the efficacy and safety of stereotactic radiosurgery plus TTFields compared to stereotactic radiosurgery alone in patients with brain metastases resulting from NSCLC.
QINLOCK (Ripretinib)
QINLOCK is a switch-control tyrosine kinase inhibitor engineered to broadly inhibit KIT- and PDGFR -mutated kinases. It is the only therapeutic approved in the United States and China for advanced gastrointestinal stromal tumor (GIST) patients who have received prior treatment with three or more kinase inhibitors in the all-comer setting.
Recent Product Highlight
As of June 30, 2022, QINLOCK has been listed in 73 supplemental insurance plans since its commercial launch in China in May 2021.
Anticipated 2022 Zai Milestone
Seek National Reimbursement Drug List (NRDL) inclusion for a fourth-line GIST indication.
Adagrasib is a highly selective and potent oral small-molecule inhibitor of KRASG12C for treating KRASG12C-mutated NSCLC, colorectal cancer (CRC), pancreatic cancer, and other solid tumors.
Recent Product Highlights
In July 2022, Zai Lab treated the first patient in Greater China for the global Phase 3 KRYSTAL-12 study of adagrasib in patients with KRASG12C-mutated advanced NSCLC.
In June 2022, Zai Lab treated the first patient in Greater China for the global Phase 3 KRYSTAL-10 study of the combination of adagrasib and cetuximab in patients with KRASG12C-mutated advanced CRC.
In June 2022, Zai Lab partner Mirati Therapeutics, Inc. (Mirati) presented the following information at the 2022 ASCO Annual Meeting
-Mirati reported full results from the registration-enabling Phase 2 cohort of the KRYSTAL-1 study evaluating adagrasib in patients with previously treated NSCLC harboring a KRASG12C mutation these results were concurrently published in the New England Journal of Medicine. This presentation included results from a retrospective subgroup analysis from the Phase 2 NSCLC cohort of the KRYSTAL-1 study evaluating adagrasib in patients with KRASG12C-mutated NSCLC and stable, previously treated CNS metastases.
Summary of clinical results from the Phase 2 registration-enabling study (n 112) initial results showed that the ORR was 43%, the disease control rate (DCR) was 80%, the median duration of response (mDOR)
was 8.5 months (95% CI 6.2 - 13.8), the mPFS was 6.5 months (95% CI 4.7 - 8.4). With a January 15, 2022 data cutoff, the median overall survival (mOS) was 12.6 months (95% CI 9.2 - 19.2).
Central nervous system (CNS)-specific activity was evaluated in a subset analysis of stable, previously treated CNS metastases (n 33) results revealed an intracranial (IC) ORR of 33% (11 33).
-In addition, Mirati reported updated findings from a pooled analysis from the KRYSTAL-1 study, including the registrational Phase 2 and Phase 1 1b NSCLC cohorts.
Pooled analysis of KRYSTAL-1 NSCLC cohorts (n 132) initial results showed that the ORR was 44% and the DCR was 81%. The mDOR was 12.5 months and the mPFS was 6.9 months. With a January 15, 2022 data cutoff, the mOS was 14.1 months.
In June 2022, Mirati also announced the results of a prospective analysis from the Phase 1b cohort of the KRYSTAL-1 study evaluating IC responses of adagrasib in patients with KRASG12C-mutated advanced NSCLC with active and untreated CNS metastases.
-CNS-specific activity in active and untreated CNS metastases (n 19) results showed an IC ORR of 32% (6 19).
Anticipated 2022 Partner Milestones
Tolerability and ORR update for the Phase 2 KRYSTAL-7 study of adagrasib in combo with pembrolizumab in first-line KRASG12C-mutated NSCLC in the fourth quarter of 2022.
Additional clarity on the regulatory pathway of adagrasib monotherapy in first-line KRASG12C-mutated NSCLC, and next steps for tumors other than NSCLC.
Potential FDA (Food and Drug Administration) approval and commercial launch in the United States for adagrasib as the treatment for patients with NSCLC harboring the KRASG12C mutation who have received at least one prior systemic therapy Prescription Drug User Free Act (PDUFA) target action date of December 14, 2022.
Bemarituzumab is a potential first-in-class antibody that is being developed in gastric and gastroesophageal junction (GEJ) cancer as a targeted therapy for tumors that overexpress FGFR2b.
Recent Product Highlights
Zai Lab partner Amgen reported that the final analysis of the FIGHT study, a Phase 2 randomized, double-blind, controlled study evaluating bemarituzumab and modified FOLFOX6 (mFOLFOX6) in patients with previously untreated advanced gastric and GEJ cancer was completed. These results continued to demonstrate that bemarituzumab + mFOLFOX6 improves the clinical outcome of patients with FGFR2b expressing tumors with no new safety concerns. A greater survival benefit was observed with increasing FGFR2b expression levels.
Zai Lab partner Amgen has initiated a Phase 1b 2 study (FORTITUDE-301), evaluating the safety and efficacy of bemarituzumab monotherapy in solid tumors with FGFR2b overexpression.
Anticipated 2022 Zai Milestone
Initiate a registrational study of bemarituzumab in first-line advanced gastric and GEJ cancer in Greater China in the fourth quarter of 2022.
Odronextamab is a bispecific antibody designed to trigger tumor killing by linking and activating a cytotoxic T-cell (binding to CD3) to a lymphoma cell (binding to CD20).
Anticipated 2022 Partner and Zai Milestone
Complete enrollment in a potentially pivotal Phase 2 study in B-Cell Non-Hodgkin Lymphoma (B-NHL).
Anticipated 2022 Partner Milestone
Report additional results from a potentially pivotal Phase 2 study in B-NHL, and submit a Biologics License Application (BLA) to the FDA.
Repotrectinib is a next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and TRK A B C, with the potential to treat TKI-na ve or TKI-pretreated patients.
Recent Product Highlights
In July 2022, Zai Lab partner Turning Point Therapeutics, Inc. (Turning Point) announced receipt of positive feedback from the FDA at a pre-New Drug Application (NDA) meeting completed within the second quarter. The FDA agreed with Turning Point's plan to provide data for ROS1+ TKI-na ve and TKI-pretreated advanced NSCLC patients with at least six months of follow-up from the first post-baseline scan at the time of NDA submission.
In June 2022, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted two Breakthrough Therapy Designations (BTDs) to repotrectinib for the treatment of patients with ROS1-positive metastatic NSCLC who have received one prior line of ROS1 TKI and one prior line of platinum-based chemotherapy and for those with ROS1-positive metastatic NSCLC who have received one prior line of ROS1 TKI and no chemotherapy or immunotherapy.
In May 2022, Zai Lab and Turning Point announced that the FDA granted an eighth regulatory designation, and third BTD, to repotrectinib, for the treatment of patients with ROS1-positive metastatic NSCLC who have been previously treated with one ROS1 TKI and who have not received prior platinum-based chemotherapy.
Anticipated 2022 Zai Milestones
Complete enrollment in all cohorts of the phase 1 2 registrational TRIDENT-1 study.
Discuss regulatory pathway with the NMPA at a pre-NDA meeting in the fourth quarter of 2022.
Anticipated 2022 Partner Milestones
Anticipate providing a detailed update from TRIDENT-1 utilizing BICR analyses, including intracranial activity, at an upcoming medical conference.
Provide a clinical data update from the NTRK-positive advanced solid tumor cohorts from TRIDENT-1.
CLN-081 is an orally available, irreversible epidermal growth factor receptor (EGFR) inhibitor that selectively targets cells expressing EGFR exon 20 insertion mutations while sparing cells expressing wild type EGFR.
Recent Product Highlight
In June 2022, Zai Lab partner Cullinan Oncology presented updated data from the Phase 1 2a study in NSCLC patients with EGFR exon 20 insertion mutations at the 2022 ASCO Annual Meeting. Of the 39 patients in the 100 mg BID dose group
-16 (41%) had a confirmed PR.
-The estimated mDOR was greater than 21 months.
-mPFS was 12 months.
-The safety profile of CLN-081 was amenable for long-term treatment.
Anticipated 2022 Partner Milestone
Initiate a pivotal study following the completion of a pharmacokinetic (PK) food effect study.
Elzovantinib (TPX-0022)
Elzovantinib is an orally bioavailable, multi-targeted kinase inhibitor with a novel three-dimensional macrocyclic structure that inhibits the MET, CSF1R (colony stimulating factor 1 receptor) and SRC kinases.
Anticipated 2022 Zai Milestone
Enroll the first patient in Greater China in the Phase 1 expansion portion of the global Phase 1 2 SHIELD-1 study.
Anticipated 2022 Partner Milestones
Provide a clinical data update from the Phase 1 SHIELD-1 study.
Initiate the Phase 2 portion of the SHIELD-1 study, pending FDA feedback on data from the intermediate dose level.
BLU-945 is a selective and potent investigational inhibitor of EGFR harboring either the activating L858R or exon 19 deletion mutations combined with the acquired T790M and C797S mutations, common on-target resistance mutations to first-generation EGFR inhibitors and osimertinib, respectively, for the potential treatment of EGFR-driven NSCLC.
Recent Product Highlight
In June 2022, Zai Lab received a Clinical Trial Application (CTA) approval from the NMPA for the BLU-945 monotherapy cohort of the global Phase 1 2 SYMPHONY study in Greater China.
Anticipated 2022 Partner Milestones
Present updated BLU-945 monotherapy data and initial dose escalation data for BLU-945 in combination with osimertinib from the Phase 1 2 SYMPHONY trial in EGFR-mutant NSCLC.
Initiate additional cohorts in the Phase 1 2 SYMPHONY trial for BLU-945 in combination with other agents across multiple patient populations, including early line therapy.
BLU-701 is a selective and potent investigational inhibitor of EGFR harboring either the activating L858R or exon 19 deletion mutations combined with the acquired C797S mutation, a common on-target resistance mutation to osimertinib, for potential treatment of EGFR-driven NSCLC.
Anticipated 2022 Partner Milestone
Present initial clinical data from the Phase 1 2 HARMONY trial of BLU-701 in EGFR-mutant NSCLC.
VYVGART (Efgartigimod)
Efgartigimod is an antibody fragment designed to reduce disease-causing immunoglobulin G (IgG) autoantibodies and block the IgG recycling process. It binds to the neonatal Fc receptor (FcRn), which is widely expressed throughout the body and plays a central role in rescuing IgG from degradation.
Recent Product Highlights
In July 2022, Zai Lab announced the NMPA accepted the BLA for efgartigimod alfa injection for the treatment of adult patients with generalized myasthenia gravis (gMG) in China.
In June 2022, efgartigimod was introduced to the Hainan Bo'ao Lecheng International Medical Tourism Pilot Zone, and in July 2022, the first Chinese patient was treated with efgartigimod.
Anticipated 2022 Zai Milestones
Launch the proof-of-concept trials in two autoimmune renal diseases.
Continue to explore and advance additional indications in coordination with argenx.