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    Home > Medical News > Latest Medical News > 2020 ASCO-multiple myeloma new drug research and development point of view

    2020 ASCO-multiple myeloma new drug research and development point of view

    • Last Update: 2020-06-17
    • Source: Internet
    • Author: User
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    The annual ASCO is a big stage for cancer researchers across the United States and around the world to showcase the results of clinical studiesMultiple myeloma (multiple myeloma) is a minor part of the carnivalBut don't see a small group, celgene is the company that developed the multiple myeloma drug to growLenalidomide 2022 sales are expected to reach a size of $13.44 billion and are also a leader in anti-tumor drugsSo in this field, pharmaceutical companies will not be taken lightlyIn an effort to address the pressure of Lenalidomide to expire patents, The New Gene (Celgene) has been laid out early in the development of new drugsMultiple myeloma drug development, after proteanasomes, histone deacetylase nas, immunomodulator, CD38 antibody development process, the next important target is BCMAtarget, Car-T, ADC, Bispecific antibody are the three pillarsAs a leader in the development of this new target drug, GSK, BMS, Johnson and Johnson each came to the market with their fist productsWhy is it a rush rather than a high-profile appearance? Because Multiple myeloma's exclusive stage is ASHSay three companies just half a year ago in THE ASH light, this ASCO does not come and a little sorry for the audience, but the three companies rushed to the scene of the mood is very different1) Car-T therapy2020 ASCO, BMS was supposed to come to the fore for its fist product Idecabagene vicleucel (Idel-Cel) pre-launch, but BLA was rejected by the FDA in early May and was in a bad moodObjectively speaking, Pivotal Phase 2 KarMMar's data is still pretty goodIn a clinical trial of 128 people, there were three doses (150x106, 300x106, and 450x106cells), in 300x106, and 450x106 cells, ORR is 69% and 82%, CR/sCR is 29% and 35%, doR 9.9-11.3pm, Median PFS 5.8-11.3monthThese patients are patients who relapsed after proteasomes, immunomodulator, CD38 antibody treatment, and this data cannot be said to be excellent, but the reason for the approval is some details in the CMCOne reason for the merger with the new gene as BMS is to be bullish on Idel-Cel's lead, which is certainly the frontrunner in the BCMA Car-T spaceHowever, BMS or new genes are still very thick in Car-T's product line, and another product, Orvacabtagene autoleucel (Orva-cel), is provided by JUNO and is designed to be similar to Idel-cel, but with a different cell preparation processThe core technology is to add PI3 Kinase put, which makes the Car-T component more of the T-central memory cell, and the regression analysis of the therapeutic results of CD19 proves that T central memory cell is very relevant to the responseThe experiment currently recruits 47 patients, divided into five doses (50x106, 150x106, 300x106, 450x106, and 600x106 cells), of which 300x106 and 450x106 dose group effects are pleasing, ORR 95%, CR 450x106650%Johnson and Johnson are also leaders in the development of multiple myeloma new drugs, cd38 antibodies in the treatment of Multiple myeloma a significant shareBCMA Car-T JNJ-4528, recently partnered with Legendary Pharmaceuticals of Nanjing, China, is amazing in its current BCMA target! The 2019 ASH's second appearance attracted a lot of attention, with an impressive 100 percent ORR and 69 percent CRIn fact, the efficacy of this product has been in doubt, the reason is very simple, because this is China's original productsThe original experiment was Legend-2, the data was very good, but the experiment was done in China, and PI was all Chinese, using a jargon to good to be trueThis time Johnson and Johnson's data is all done in the United States, everything is international standardSo the results are credibleAs soon as 2019 ASH was over, the FDA qualified for the JNJ-4528 breakthrough therapy, and it was clear that the FDA highly valued the efficacy of JNJ-4528This time Johnson and Johnson came to ASCO in a relaxed mood, because half a year later, clinical efficacy was not only stable but also tested, because CR increased from 69% to 86% today, a non-palm encouraging figure that shows that JNJ-4528 not only maintains existing efficacy, but can even continue to improve the efficacyThe results of clinical trials are often the first phase is better than the second phase, the second phase is better than the third phase, and the short-term is better than the long-termThe six-month interval between JNJ5428 is good news for improved efficacy2) The ADCBMS horse loses its front hoof, reducing stress to GSKGSK's Belantamab mafodotin is the leader in BCMA ADC therapy Starting in 2014, a good response was seen in a phase itrial trial codenamed Dreamm-1, with an ORR of 60 percent, and patients who relapsed after more than three treatments Last year ASH published the results of Pivotal Phase 2 Dreamm-2 clinical trials, although the response rate is lower than Dreamm-1, but the two Dose 2.5 mg/kg (N-97), dose 3.4 mg/kg (N-99) or reach ed31 % and 35% VGPR (very good partial response) reached 19% and 24%, and 53% of patients are expected to live through a year Compared to the preparation process of Car-T, the aDC preparation method has an advantage The side effects of GSK ADC therapy are different from Car-T, with side effects of the eyes being a feature that affects delayed administration, lower dose, etc But that doesn't affect GSK's confidence in its products GSK has designed nearly eight Phase III clinical trials in the multiple myeloma, using different combinations, and striving to get ahead of the first-line second-line therapies, with the combination of ICOS and OX40 and Belantamab mafodotin In January, the FDA granted Belantamab mafodotin priority review, and Belantamab mafodotin's filing this year was expected 3) Bi-specific antibody as a double antibody efficacy method, CD3/BCMA, major pharmaceutical companies are still in the initial stage, small sample size, clinical data is small, Johnson and Johnson, BMS, Pfizer, Regeneron data is still relatively early, from the results already available, to achieve Car-T effect is not easy, but Bi-specific antibody in the preparation and use still has an advantage 4) Non-BCMA Target
    a good target from discovery to certainly not easy, in addition to BCMA, what good target? This year ASCO, BMS presented a new protein degradation platform product CC-92480, which is E3-ligase modulator, degradable IKaros, Aiolos (reverselenalidomide resistance), in a 76-person first clinical experience, patients are mostly patients who relapse after three treatments, currently performing well, with OOR 54%, and other data is still very early drug source analysis
    we are living in a great era, China's pharmaceutical industry is experiencing unprecedented opportunities for development, from imitation to me too to me better, accumulated a lot of experience and self-confidence, now in the next field of cell therapy, almost can be synchronized with the world BCMA has been a target for the development of new multiple myeloma drugs for some years, and ADCs are relatively early, and CAR-T has been a thing of the past few years In car-t, america's leading position is indisputable, but China's development should be said not to be slow The two furthest bcMA-Car-Ttherapys go today are actually BMS/Celgene's Bluebird/JUNO JNJ-4528 is the legend of Nanjing, China, under Johnson and Johnson in the bcMA Car-T field, Nanjing Legends products, has entered the leading position BCMA Car-T, in China not only has the Nanjing legend, in 2019 ASH, there are several Chinese companies with very bright clinical data BCMA Car-T is just a microcosm of the development of Car-T blood tumors in China and is also on the rise in the field of solid tumors At the just-concluded 2020 ASGCT annual meeting, data from a Chinese company treating thymus and colon cancer sidon go up in the eye, and if repeated in future large samples, it must be another legend in the history of Chinese pharmaceuticals One bottleneck in the development of car-T pharmaceutical is the preparation of CMC for cell products This area is basically new, and even the BIG business BMS is not satisfied, otherwise the FDA will not let it add data That year Novartis bought a cell production facility for a cell therapy company to develop cell therapy Carl June, the Car-T ancestor, was impressed that when it came to CMC, it would not be possible to get involved without a big company Even when cell therapy is on the rise, Chinese drug companies engaged in cell therapy must focus on CMC to build, in order to ensure the supply of products after the market In addition, the preparation of cell products is also a good CRO business opportunities, Chinese pharmaceutical counterparts can be laid out in advance Original title: 2020 ASCO, several points of view for multiple myeloma new drug development
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