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Blood cancer research has never been more dynamic, more productive, or more global. And that is a good thing for patients.
There are countless new treatments in clinical trials for various types of lymphoma, leukemia, myeloma and other blood cancers. And they're coming from companies worldwide.
Some of these new and promising modalities such as CAR T-cell immunotherapy, bispecific antibody treatment, gene therapies, natural killer (NK) treatments, targeted therapies, and more are already in the clinic, while many more are making their way through clinical trials.
Among the most successful new types of treatment for blood cancers are the Bruton's tyrosine kinase (BTK) inhibitors.
These treatments inhibit the enzyme BTK, which is a crucial part of the B-cell receptor signaling pathway. Certain B-cell leukemias and lymphomas use B-cell receptor signaling for growth and survival.
BTK inhibitors can block this signaling and trigger the death of a cancer cell.
In the last several years, the clinical use of BTK inhibitors have changed the treatment landscape for chronic lymphocytic leukemia (CLL).
BTK inhibitors in fact are the first targeted therapies to demonstrate a major improvement in progression-free survival for CLL patients compared with chemotherapy or chemo-immunotherapy.
Three different so-called BTK inhibitors -- Imbruvica from Pharmacyclics and Janssen, Calquence from AstraZeneca, and Brukinsa from BeiGene -- are already in the marketplace, and several more are being tested.
Among the new generation of BTK inhibitors, one of the most promising is orelabrutinib from InnoCare, a relatively new biopharmaceutical company that incorporated in China in 2015 and already has a presence in the United States.
InnoCare is developing what are potentially first-in-class and/or best-in-class drugs for the treatment of several types of cancer.
The focus is on patients with blood cancers such as lymphoma, solid tumors, and autoimmune diseases with high unmet medical needs in the U.S., China and worldwide.
InnoCare, which has branches in New Jersey, Boston, Beijing, Nanjing, Shanghai, Guangzhou and Hong Kong, brought more promising results to the recent American Society of Hematology (ASH) Annual Meeting.
An updated study result further confirms that orelabrutinib effectively treats relapsed or refractory (r/r) chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
In a multicenter phase II trial, 80 patients with R/R CLL/SLL were enrolled. The overall response rate was 93.8 percent, with 26.3 percent seeing a complete response and 67.6 percent partial response.
This is a significantly higher complete response rate in comparison with other BTK inhibitors at a similar median follow-up period.
The other significant news is that orelabrutinib was found to be well-tolerated. Most adverse events were mild to moderate.
The evidence so far has shown that with each new generation of BTK inhibitor treatments, the efficacy and safety of the drug tends to improve.
In an exclusive interview with The Reno Dispatch, Sean Zhang, InnoCare's Chief Medical Officer, said the updated data that was presented at ASH further confirms that orelabrutinib is effective in treating relapsed or refractory CLL patients with a relatively high rate of complete remission and durable response.
Orelabrutinib had received approval on Dec. 25, 2020 from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with r/r CLL/SLL, and the treatment of patients with r/r MCL.
InnoCare is conducting a clinical study in US for both r/r MCL and r/r CLL/SLL indications. The FDA has granted Breakthrough Therapy Designation (BTD) to orelabrutinib for treatment of r/r MCL.
The InnoCare story is a remarkable one, for several reasons. The ascension of CEO Jasmine Cui, PD, is a positive story in and of itself.
A woman CEO at a major China biotech company had until recently been a rarity. But Cui has been described as one of the most innovative and brilliant cancer scientists and executives in the world. The company incorporated in 2015 and has a U.S. office in Princeton, NJ.
Regarding the company’s lead product, orelabrutinib, Zhang said the drug is still in trials in the US, but it looks very promising.
"We have seen CLL patients with significantly higher complete response rates than other BTK inhibitors, durable response, and improved safety profiles,” he said.
"Orelabrutinib provides a favorable therapeutic choice for patients with R/R CLL/SLL and has great potential to be the best candidate for the combination therapy.”
In addition to lymphoma, orelabrutinib shows great potential to treat such autoimmune disease as multiple sclerosis (MS).
With the ability to cross the blood brain barrier, orelabrutinib has the potential to provide a clinically meaningful benefit on progression in all forms of MS.
In July, 2021, InnoCare and Biogen, another international biotech company based in Cambridge, Mass., entered into a license and collaboration agreement for orelabrutinib for the potential treatment of MS.
This latest collaboration further illustrates InnoCare's international commitment to patients.
