This article has been corrected to reflect that EQRx went public via a $1.3 billion special purpose acquisition company deal.
NEW YORK – The 40th Annual JP Morgan Healthcare Conference kicked off on Monday, as conference organizers pivoted to a virtual conference instead of the usual live event at the Westin St. Francis Hotel in San Francisco due to the resurgent coronavirus pandemic. Nonetheless, the conference got off to its normal busy start with several drugmakers and diagnostics and genomic tools firms making their case to investors. Below are brief reports on individual presentations webcast by the companies or through the JP Morgan conference portal.
Novartis is expecting that pipeline growth opportunities will offset approximately $9 million worth of revenue that is exposed to generic competition.
Among anticipated new therapies, for example, Novartis CEO Vas Narasimhan is confident the firm will garner the US Food and Drug Administration's approval for its radioligand 177Lu-PSMA-617, during the first half of this year for metastatic castration-resistant prostate cancer based on results from the Phase III VISION trial. This approval, Narasimhan said, will mark the first step in a multi-year plan to bring this therapy to market across multiple prostate cancer indications and make 177Lu-PSMA-617 "a linchpin of therapy for prostate cancer patients."
In terms of scaling up and ensuring patient access once this therapy is approved, Narasimhan said the mere market availability of 177Lu-PSMA-617 will increase interest among clinics and hospitals "to start to build the ability to provide these medicines." This increased interest and infrastructure investments from hospitals, Novartis hopes, will allow it to develop radioligand therapies for a range of solid tumors beyond prostate cancer as well.
Novartis also highlighted its new CAR T-cell therapy platform, T-Charge, which includes process improvements for manufacturing autologous cell therapies more rapidly and at a lower cost. The firm plans to use the platform to develop CAR T-cell therapies with improved efficacy by taking advantage of cells' "stemness," or their ability to mature and self-renew inside of the body. Using this platform, Novartis has already developed two early-phase CAR T-cell therapies, YTB323 and PHE885, for diffuse large B-cell lymphoma and multiple myeloma, respectively. Novartis reported encouraging Phase I response rates for both therapies last month and believes the new platform could allow it to "leapfrog to a place where we can scale CAR T-cell therapy at a much lower cost of goods, and hopefully, reach a broader set of patient populations."
The drugmaker also expects further growth for its CDK4/6 inhibitor ribociclib (Kisqali), which is approved for advanced hormone receptor-positive, HER2-negative breast cancer. Novartis expects to expand ribociclib into earlier indications based on recent overall survival data, potentially making it a "multibillion-dollar medicine," Narasimhan said. The firm is particularly excited to advance ribociclib as an adjuvant treatment for early breast cancer and anticipates readouts this year from the Phase III NATALEE study, evaluating ribociclib combined with endocrine therapy as adjuvant therapy for early-stage breast cancer.
Novartis will report Q4 2021 and full-year financial results on Feb. 2.
The oncology division at Gilead Sciences is on track to exceed $1 billion in revenue in 2021. According to an update from Gilead CEO Daniel O'Day, much of the growth in the segment is due to its leading position in the cell therapy space.
Gilead recently presented data from the ZUMA-7 trial evaluating its anti-CD19 CAR T-cell therapy axicabtagene ciloleucel (Yescarta; axi-cel) in second-line large B-cell lymphoma. In that study, the cell therapy significantly improved patients' event-free survival versus standard-of-care chemotherapy and stem cell transplant. Currently, axi-cel is available as a third-line treatment for relapsed or refractory LBCL patients, but the ZUMA-7 results may allow Gilead to be the first to move its CAR T-cell therapy to an earlier-line setting.
According to Christi Shaw, who leads Gilead subsidiary Kite, a second-line axi-cel approval could nearly double the patient population eligible to receive the treatment. The firm expects a decision from regulators in early April. Gilead has also begun evaluating the treatment as a frontline LBCL therapy in the proof-of-concept ZUMA-12 study, in which axi-cel treatment has demonstrated promising response rates in early analysis.
O'Day also shared updates on Gilead's TROP2-directed antibody-drug conjugate, sacituzumab govitecan, which received full US FDA approval for second-line metastatic triple-negative breast cancer last year. The expansion into the second-line setting, according to O'Day, has been a boon for the drug's uptake, with about a quarter of patients in this setting receiving the drug.
The drugmaker has plans for several combination studies, either pairing it with its own products or inking strategic partnerships. For example, Gilead announced on Monday plans to evaluate sacituzumab govitecan with Merck's pembrolizumab (Keytruda) in first-line metastatic non-small cell lung cancer. Gilead also intends to initiate more than 20 new oncology clinical trials in 2022, seven of which will be Phase III trials involving sacituzumab govitecan in multiple tumor types including breast, bladder, and lung cancers.
Gilead will report Q4 2021 and full-year financial results on Feb. 1.
Johnson & Johnson
Although Johnson & Johnson experienced a hiccup with its CAR T-cell therapy program ciltacabtagene autoleucel (cilta-cel) toward the end of 2021, CEO Joaquin Duato remains confident that the firm will garner approval for the drug in relapsed or refractory multiple myeloma this year. J&J was expecting to hear from the US Food and Drug Administration last year about its application for the drug in relapse or refractory multiple myeloma. However, in November, J&J announced that the agency had delayed its decision so it would have more time to review information "pertaining to an updated analytical method" that the company submitted upon request.
Despite this, Duato is anticipating cilta-cel's approval this year given promising efficacy in clinical trials. For example, in the CARTITUDE-1 trial, the objective response rate was 97 percent, with 67 percent achieving stringent complete responses. "And oh, by the way, we're also doing clinical trials of Carvykti in first line, showing that we want to change the treatment paradigm there," he said, noting that since multiple myeloma patients still face a poor prognosis, it's important for drugmakers to aim to not only extend life for those with advanced disease but also cure patients with earlier lines of therapy.
J&J is also exploring combination treatment strategies with cilta-cel. The combination of cilta-cel with J&J's CD38-targeting monoclonal antibody daratumumab (Darzalex) and its bi-specific antibodies under development, such as teclistamab, has the potential to change the treatment paradigm in multiple myeloma, Duato said.
Additionally, the company is studying combination approaches with its c-met/EGFR antibody amivantamab (Rybrevant), which was approved by the FDA last year as the first targeted drug for NSCLC patients with EGFR exon 20 insertion mutations. Duato noted that the combination of amivantamab with lazertinib, an investigational third-generation EGFR inhibitor that penetrates the blood-brain barrier and targets the T790M resistance mutation and activating EGFR mutations, if successful in clinical trials, "can be a new standard of care for EGFR-positive NSCLC."
Bristol Myers Squibb
In 2022, Bristol Myers Squibb is focused on advancing its portfolio of specialty medicines as loss of exclusivity looms over the coming years for some of its top-selling drugs, including nivolumab (Opdivo).
BMS CEO Giovanni Caforio highlighted several precision oncology drugs either already on the market or poised to enter the market that he expects to drive growth over the next decade, including relatlimab, cell therapies, and the folate receptor-alpha drug MORAb-202.
Although the near-term market opportunity for relatlimab is in first-line metastatic melanoma in combination with nivolumab, BMS is also exploring a LAG-3 antibody-nivolumab combination in liver, colorectal, and non-small cell lung cancer, and has relatlimab programs in biomarker-defined indications, such as mismatch repair deficient solid tumors and microsatellite stable colorectal cancer.
"[Relatlimab] has the potential to extend the durability of our [immuno-oncology] franchise well into next decade," Caforio said, estimating that the drug could reach $4 billion in annual sales. He added that BMS remains confident in its entire immune-oncology portfolio through 2025, particularly since its best-selling checkpoint inhibitors nivolumab and ipilimumab (Yervoy) still have opportunities to expand into more indications and in earlier adjuvant settings.
BMS will begin registrational trials this year for MORAb-202, a folate receptor-alpha antibody-drug conjugate it is jointly developing with Eisai to treat folate receptor-alpha-positive tumors, including endometrial, ovarian, lung, and breast cancers. In 2022, BMS also expects to see another approval for its CAR T-cell therapy lisocabtagene maraleucel (Breyanzi) in second-line large B-cell lymphoma. The FDA approved the therapy last year as a third-line treatment of relapsed or refractory LBCL patients.
In 2022, BMS is expecting revenues of $47 billion with low single-digit growth. The company will report Q4 and full year 2021 results on Feb. 4.
Merck is intently planning for the inevitable loss of exclusivity of its blockbuster checkpoint inhibitor pembrolizumab (Keytruda) during the second half of this decade. To counteract the biosimilar competition that will come with pembrolizumab's key patent expirations beginning in 2028, Merck is bolstering the rest of its oncology portfolio, forming strategic partnerships, seeking out acquisitions, and capitalizing on pembrolizumab’s growth as much as possible.
While other drugmakers may be developing competing PD-1 inhibitors at potentially lower prices, Merck CEO Robert Davis underscored that pembrolizumab now has 34 approved indications across 16 different tumor types — many in precision oncology settings — and this "will make it tough to unseat" the company from the number one position in the checkpoint inhibitor market.
Merck is advancing several new agents combined with pembrolizumab, including the anti-TIGIT molecule vibostolimab and the LAG3 inhibitor favezelimab. The firm is also developing its own CTLA4 inhibitors. "We think it's important to have a broad stroke of checkpoint inhibitors to combine with Keytruda, but to be very smart as to where you're going to advance [them]," said Dean Li, president of Merck Research Laboratories.
Merck is also focused on strategic partnerships, including one announced Monday with Gilead Sciences to evaluate pembrolizumab with sacituzumab govitecan (Gilead's Trodelvy) in first-line metastatic non-small cell lung cancer. The sacituzumab govitecan pairing is just one example of Merck's broader interest in combining pembrolizumab with antibody-drug conjugates, according to Li.
The drugmaker is continuing to advance pembrolizumab in new indications and earlier treatment lines. On Monday, for example, the firm shared results from its KEYNOTE-091 trial, in which adjuvant pembrolizumab improved disease-free survival versus placebo in early-stage NSCLC patients regardless of PD-L1 status. Interestingly, the trial met its co-primary endpoint, showing that pembrolizumab improved disease-free survival over placebo in the allcomer population but did not reach statistical significance in the PD-L1-high group. Li said Merck is discussing the findings with the US Food and Drug Administration and "both them and us see a path forward in terms of filing."
In its overall business, Merck expects strong, continued revenue growth through the coming year, and will report its Q4 2021 and full-year financial results on Feb. 3.
BridgeBio Pharma CEO Neil Kumar provided updates on several therapeutic programs, including the selection of a first-in-class direct inhibitor of GTP-bound and GDP-bound KRASG12C during the first half of this year, which could enter clinical trials during early 2023.
According to early research, Kumar said that the candidate could have a leg up on Amgen and Mirati Therapeutics' first-generation KRASG12C inhibitors, which only block GDP-bound KRAS. BridgeBio's agent could also potentially overcome resistance to these agents, Kumar said.
The firm is also advancing an agent that breaks the PI3K-RAS interface. Kumar explained that in xenograft models this mechanism of action appeared to have advantages over PI3K inhibitors like alpelisib (Novartis' Piqray). For this program, BridgeBio also anticipates selecting a candidate this year, which it will take into the clinic in 2023.
Additionally, Kumar said that BridgeBio has a competitive KRASG12D inhibitor program in the lead optimization stage that looks promising as well as programs to develop a pan-KRAS inhibitor and a KRASG12R inhibitor, which are currently in lead optimization and lead generation stages, respectively.
According to Kumar, BridgeBio has a current cash balance of $800 million and can access an additional $300 million if it achieves proof of concepts this year within certain portfolio programs.
Samantha Du, founder and CEO of Zai Lab, highlighted the company's position as a "partner of choice in China" for commercializing innovative precision oncology drugs, and provided updates on the company's growing pipeline. Last year, Shanghai-based Zai Lab made eight licensing deals, for example, with Mirati Therapeutics for its KRAS inhibitor adagrasib; with Blueprint Medicines for its EGFR inhibitors BLU-945 and BLU-701; and with Turning Point Therapeutics for its MET inhibitor TPX-0022.
In 2022, the firm expects to begin a Phase III trial of the FGFR2 inhibitor bemarituzumab, licensed from Five Prime Therapeutics, in gastric cancer. The Center for Drug Evaluation within China's National Medical Products Administration recently granted breakthrough therapy designation to bemarituzumab plus chemotherapy as a first-line treatment for patients with FGFR2b-overexpressing, HER2-negative advanced gastric or gastroesophageal junction cancer.
"We were pioneers of [the] licensing strategy in China and have firmly established Zai as partner of choice," said Tao Fu, chief strategy officer at Zai Lab. "Looking at our business development track record, we've had more quality deals than any other Chinese company since our IPO in 2017."
Zai Lab also expects the Chinese government to continue investing in the biopharma sector and streamlining the regulatory process, Du said. Chinese regulators have changed intellectual property laws to correspond with global standards, approved an increasing number of new drug applications annually, and shortened the time to approval for drugs on China's National Reimbursement Drug List — a program started in 2000 to improve access and reimbursement to hospital-purchased drugs.
"It's clear that the Chinese government strongly supports development and commercialization of innovative drugs," Du continued. "The Chinese government has made innovative life sciences one of the pillar industries. We intend to take full advantage of these positive developments."
Zai Lab is also advancing precision oncology drugs based on its own R&D. "We started our internal discovery effort five years ago, and our strategy for internal R&D is to prioritize programs synergistic with our in-license portfolio," Du said.
The company has four oncology candidates in early development, including drugs targeting CDC7, DNA-dependent protein kinases (DNA-PK), CD47, regulatory T-cells (Treg), and Caludin 18.2. Zai expects to file investigational new drug applications this year for its DNA-PK candidate ZL-2201 and its Treg candidate ZL-1218.
In 2021, Erasca launched Phase I/II clinical trials of its ERK and SHP2 inhibitors and advanced its preclinical KRAS and EGFR inhibitor programs closer to the clinic.
Erasca CEO Jonathan Lim believes Erasca's ERK inhibitor ERAS-007 "could become a backbone of combination therapy for tumors with activated RAS/MAPK pathways." To that end, the company began exploring the drug's activity both as a single agent and in combination with other targeted therapies in a series of trials dubbed HERKULES.
In HERKULES-1, the company is studying single-agent ERAS-007 in RAS/MAPK-altered solid tumors. In HERKULES-2, Erasca is studying the drug in EGFR- and KRAS-mutated lung cancer in combination with osimertinib (AstraZeneca's Tagrisso), sotorasib (Amgen's Lumakras), and other agents. In HERKULES-3, the firm is evaluating ERAS-007 in BRAF-, KRAS-, and NRAS-mutant gastric cancers in combination with encorafenib (Pfizer's Braftovi), cetuximab (Eli Lilly's Erbitux), and palbociclib (Pfizer's Ibrance).
The company expects readouts from these studies in 2022 and 2023, Lim noted, including data on safety, pharmacokinetics, and preliminary efficacy. The HERKULES-1 results will help guide further studies by establishing a dose and dosing schedule for ERAS-007, Lim said. Additionally, in Q1 2022, Erasca expects to begin a trial exploring the combination of ERAS-007 and gilteritinib (Astellas Pharma's Xospata) in FLT3-mutant acute myeloid leukemia.
The firm also began a Phase I trial last year, called FLAGSHP-1, to explore ERAS-601 in RAS/MAPK-altered solid tumors. Lim expects early data from FLAGSHP-1 in the second half of 2022. Lastly, the company is on track to file an investigational new drug application for its KRAS G12C inhibitor ERAS-3490 in non-small cell lung cancer in the second half of 2022.
"We have an unprecedented portfolio to erase cancer targeting the RAS/MAPK pathway with our ERAS programs," Lim said. "We have two clinical stage compounds and a third soon to enter the clinic, with multiple near-term and long-term value drivers." As of Sept. 30, 2021, Erasca had about $487 million in cash and cash equivalents, which gives the firm more than two years of a cash runway to advance its programs.
EQRx, a company which went public via an $1.3 billion special purpose acquisition company deal with CM Life Sciences III last year, will conduct head-to-head comparisons of its lead pipeline assets against standard-of-care treatments in an effort to give doctors and payors the types of data they need to make treatment and coverage decisions.
The Cambridge, Massachusetts-based company, which launched in 2020 with the goal of efficiently developing drugs and aggressively competing on price, has two cancer drugs in late-stage development: aumolertinib for the treatment of non-small cell lung cancer with EGFR mutations and sugemalimab, an anti-PD-L1 antibody also being studied in NSCLC. The company also has a slew of partnerships and memorandums of understanding (MOU) with payors and health systems in the US and abroad covering more than 180 million lives, aimed at reducing drug spend and making therapies more accessible.
Some of the arrangements the company has announced involve BlueCross BlueShield of North Carolina, the National Health Service England, and Geisinger Health. On Monday, EQRx announced an MOU with CVS Health to "to accelerate the commercial availability of lower-cost specialty therapeutics and create cost savings for CVS Health clients, patients and members through the adoption of EQRx medicines" that garner regulatory approval.
EQRx CEO Melanie Nallicheri said that in inking these partnerships, the company has already shared preliminary data on its lead assets and is generating more evidence that will convince payors of the value of its drugs. For example, EQRx and its partner Hansoh Pharma already have Phase III data showing that aumolertinib improves progression-free survival and has a better safety profile than gefitinib (AstraZeneca's Iressa) in first-line EGFR-mutated NSCLC.
The company this year is also planning to start a three-arm trial comparing single-agent aumolertinib versus aumolertinib plus chemotherapy versus the EGFR inhibitor osimertinib (AstraZeneca's Tagrisso). Similarly, for the PD-L1 inhibitor sugemalimab, which is already approved in China as a first-line advanced NSCLC treatment, the company is planning a head-to-head comparison in the US with other approved checkpoint inhibitors.
"We're not just doing this with one single goal in mind, which is regulatory approval," Nallicheri said. "We're very much committed to generating what we call evidence to adoption, [which is] evidence our payor partners will want to see [and] evidence physicians will want to see."
This strategy will allow the company to demonstrate the value of its drugs to health authorities in countries with single-payor systems where therapies must demonstrate efficacy, safety, and cost-effectiveness. "It is an absolutely necessary condition for an EQRx medicine to be equally good or better in a class," Nallicheri said. "We are not going to ask anyone, ever to make a tradeoff and say, 'Well, it's not as good, but it's much lower cost.'" She emphasized that EQRx's medicines will need to "stand on their own" in terms of efficacy and safety data. "The clinical quality comes first," Nallicheri said. "The pricing comes second."
Additionally, EQRx is committed to "diversity and inclusivity" in its R&D efforts. According to Nallicheri, the "EQ" in the company's name stands for "equitable pricing" and "equal access." As such, the company will study its drugs in diverse patient populations. For example, she highlighted that in addition to the Phase III data that the firm already has for aumolertinib, EQRx is gathering additional evidence to show the drug works equally well in diverse cohorts.
Since its launch two years ago, EQRx has raised $2 billion and hired 250 employees. The company expects to make regulatory filings for its lead programs in the second half of 2022. By year end, the company hopes to ink more partnerships with payors so that it is working with entities that together provide insurance for more than 350 million lives.
Mirati Therapeutics closed out 2021 by submitting a new drug application to the US Food and Drug Administration for adagrasib in second-line KRAS G12C-mutated advanced non-small cell lung cancer. The San Diego-based firm began studying adagrasib in first-line NSCLC patients with a tumor proportion score of less than 1 percent for the KRAS G12C mutation and STK11 co-mutations.
Additionally, Mirati inked two different deals with Verastem Oncology and Sanofi to study adagrasib in combination with their drugs, the RAF/MEK inhibitor VS-6766 and the SHP2 inhibitor SAR442720, respectively. The company also shared preliminary data from the Phase II KRYSTAL-7 trial on the combination of adagrasib and pembrolizumab (Merck's Keytruda) in first-line NSCLC, which has enabled the firm to identify an appropriate adagrasib dose to take into further studies.
Given these milestones, Mirati CEO David Meek characterized 2021 as a "breakthrough year" for the company and said that 2022 also stands to be a "transformational" one as it is anticipating FDA approval for adagrasib in advanced KRAS G12C-muated NSCLC.
Although Amgen was the first to market in the KRAS G12C-mutated advanced NSCLC space with sotorasib (Lumakras) last year, Mirati is hoping to differentiate adagrasib in the market having seen encouraging early clinical activity against brain metastasis. The drug's differentiated molecular profile is enabling Mirati to pursue a "broad and aggressive" development plan, Meek said. For example, the company is studying adagrasib in combination with cetuximab (Eli Lilly's Erbitux) in second- and third-line colorectal cancer. Adagrasib has also shown promising early activity in pancreatic cancer.
Having observed adagrasib's activity across a variety of tumor types, Charles Baum, president, founder, and head of R&D at Mirati, said the company is considering conducting a pan-tumor trial. "We need to have a discussion with the [FDA] about what the breadth of that [trial] would be and which tumor types to include," Baum said, highlighting for example that there are patients with cancers of unknown primary and KRAS G12C mutations. "We want to find a way to include them in the registration program."
Mirati also has a KRASG12D inhibitor, dubbed MRTX1133, in lead optimization across various tumor types including NSCLC, pancreatic cancer, and colorectal cancer and a synthetic lethal PRMT5 inhibitor, dubbed MRTX1719, also in lead optimization phase in MTAP-deleted cancers. A SOS1 inhibitor and a mutant KRAS inhibitor are in discovery phase for solid tumors.
Mirati is planning to file an investigational new drug application with the FDA in the second half of 2022 for MRTX1133 that will allow it to begin studying it across KRAS G12D-mutated cancers. The FDA has cleared Mirati's IND application for MRTX1719 allowing it to start a Phase I/II trial in MTAP-deleted cancers Q1 2022.
"We have adequate capital to invest appropriately in our portfolio and our capabilities and are backed by the right expertise and resources enabling us to stay ahead of the innovation curve," Meek said. As of Sept. 30, 2021, Mirati has $1.2 billion in cash, cash equivalents, and short-term investments as well as net proceeds of $475 million from a November 2021 follow-on offering.
In oncology, Natera expects results from the Circulate-IDEA trial of its Signatera minimal residual disease colorectal cancer test to be reported at the ASCO-GI conference in two weeks.
Natera CEO Steve Chapman said the goal for Signatera over the next two years is to gain endorsement in National Comprehensive Cancer Network guidelines for colorectal cancer as well as the Centers for Medicare and Medicaid Services and private payor coverage for five other cancer types.
Three years after going public, Guardant Health now has 200 million covered lives, has $1.7 billion on its balance sheet, and has witnessed a compound annual growth rate of 59 percent. It boasts more than 250,000 tests ordered by an excess of 11,000 ordering oncologists, and approximately 100 biopharma partners.
Co-CEO Helmy Eltoukhy noted the firm went from a single product 18 months ago to five products currently.
Its Guardant 360 liquid biopsy assay continues to see strong adoption, and the company has also launched Guardant 360 Response and Tissue Next tests and Guardant Reveal. Eltoukhy added the Guardant 360 CDx test was the first comprehensive liquid biopsy assay to receive FDA approval.
The firm now has more than 250 publications describing its assays, has numerous trials in progress, and expects that this year will mark "a new chapter at Guardant," with offerings across the continuum of cancer care, co-CEO AmirAli Talasaz also said.
For Guardant Reveal, which launched in 2021, the firm expects to move beyond colorectal cancer to multicancer testing with results from the Observation of Residual Cancer with Liquid Biopsy Evaluation, or ORACLE, study of 11 solid tumor types. The firm is targeting 30 trial sites in the US and Spain and enrolling more than 1,000 patients in the prospective observational study. The results may unlock $20 billion in total addressable market for minimal residual disease testing across all tumor types.
So far, Reveal has also shown strong performance for MRD detection in CRC and breast cancer, with integration of genomic and epigenomic ctDNA signals increasing sensitivity by as much as 2.5 times.
Guardant will also launch the Smart liquid biopsy platform this year, which will be 100 times larger and have higher sensitivity than its 360 CDx, enabling the evaluation of genomic, epigenomic, and immune signatures.
Talasaz presented a business thesis of dramatic growth by 2023 in the cancer screening domain of its business. The firm expects results from its ECLIPSE trial this year and to submit the Next Generation Guardant Shield cancer screening test to the FDA in the second half and to launch the test as an LDT in the first half of the year. The test will be 30 times larger, advancing from a panel size of 500kb to 16MB.
The firm expects its prospective lung cancer trial, called SHIELD Lung, of approximately 10,000 high-risk patients to have the potential to enable FDA approval and Centers for Medicare and Medicaid Services coverage.
Adaptive Biotechnologies CEO Chad Robins described development efforts in the company's minimal residual disease testing business for hematologic cancers. Robins said Adaptive believes its ClonoSeq assay continues to lead in both clinical testing and in support of pharmaceutical trials for hematologic cancers.
"While clinical utility has been a barrier to adoption in the past, this is changing quickly, and we see multiple studies reading out to demonstrate the value of MRD testing for patients," he said, highlighting data from the MASTER trial, which Adaptive presented at the recent meeting of the American Society for Hematology.
Analyses of patient outcomes suggested that if an individual with multiple myeloma tests MRD negative with ClonoSeq, they can stop therapy, "giving relief to patients from side effects and at the same time, saving substantial cost to the healthcare system."
Among key growth drivers expected to help Adaptive maintain a leadership position in the field, Robins highlighted the firm's heavy investment in new data generation. Most immediately, the company plans to expand into non-Hodgkin's lymphoma, where MRD can complement or supplant imaging for disease burden monitoring and early detection of relapse.
To support these goals, Adaptive is increasing its field force, expecting to have new diagnostic hematology specialists and account managers trained and in the field by the second quarter of this year. "We are still at the beginning of the adoption curve," Robins said, "[but] we are well positioned to increase adoption significantly and look forward to a very successful year for our MRD business."