Roche/Genentech CMO Levi Garraway
Breakthroughs in drug development have begun to unlock the potential of antibody-drug conjugates, therapies designed to better target proteins on tumor cells. Genentech’s Polivy has become an early winner in blood cancer, and now the drugmaker is revealing promising results in getting into patients even sooner.
A combination of Roche’s Polivy, an ADC targeting the CD79b protein on tumor cells, with Rituxan and the chemotherapy regimen R-CHOP cut the risk of disease progression or death over Rituxan-chemo alone by 27% in patients with first-line diffuse large B cell lymphoma, according to late-breaking data presented Tuesday at #ASH21.
In the 879-enrollee Phase III POLARIX study, patients dosed with the Polivy combo showed significant improvement on median progression-free survival at a 28.2-month check-in, Genentech said.
Meanwhile, the ADC-based combo posted a Grade 3-4 side effect rate of 57.7% compared with 57.5% for the SOC chemo combo. Three percent of patients died in the treatment arm compared with 2.4% in control, and 9.2% of patients in the Polivy arm discontinued due to dosing compared with 13% in the Rituxan-chemo arm.
These full data back up topline results that were released back in August, with Roche touting Polivy’s chances at significantly extending patients’ lives for a disease in which four of 10 patients eventually relapse after treatment with SOC in the first-line setting. The drug works by targeting CD79b on the surface of B cells and delivering an anti-cancer agent to the site.
Polivy was developed from ADC technology at Seagen. Roche has already submitted what it had on hand with global health regulators, with these results backing up those filings.
The current generation of ADCs has shown some significant breakthroughs in the treatment of solid tumors, including drugs like AstraZeneca and Daiichi Sankyo’s Enhertu, which targets the HER2 protein on tumors. Meanwhile, in blood cancer, a new generation of ADCs has recently broken through, including Polivy, which was initially approved in 2019 in combination with Rituxan as a treatment for relapsed or refractory DLBCL.
These newest data also add more validity to targeting CD79b as part of a range of cancer combinations, potentially offering physicians more paths to killing tumors. In lymphoma, CD19 and CD20 have cemented themselves as the most prolific targets among cancer drugs, but Roche has looked to partner up Polivy alongside Rituxan, itself a CD20 monoclonal antibody, among other team-ups.
Those combo studies include combining Polivy with Genentech’s in-house bispecific antibodies mosunetuzumab and glofitamab, both of which target CD20. The drugmaker is also looking at Polivy combos with the BCL-2 inhibitor venetoclax, and with Rituxan in combination with chemotherapies gemcitabine and oxaliplatin in the Phase III POLARGO study.
Sensor-based technology for clinical trial data collection represents the latest medical paradigm shift. There are more than 700 clinical studies involving wearable devices currently underway in the United States. A study from Intel IT projects their inclusion in clinical trials will surge to 70% by 2025.
Apps, biosensors and patient-centered technologies increase visibility of comprehensive patient data. Pharma leaders anticipate the benefits of wearables to include better data (58%), faster results (33%) and lower trial costs (10%).
When Bristol Myers Squibb celebrated the approval of ozanimod — branded Zeposia — in ulcerative colitis earlier this year, the company touted the first gastrointestinal indication for an S1P receptor modulator.
Now Pfizer wants to give the pharma rival a run for its money.
Pfizer is dropping $6.7 billion to acquire Arena Pharmaceuticals, whose lead drug, etrasimod, targets the sphingosine 1-phosphate receptor.
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Rob Califf, the famous cardiologist from Duke University, is likely to return to the top of the FDA, this time under the Biden administration.
At his confirmation hearing Tuesday, Democrats and Republicans on the Senate health committee offered their support for Califf, with Chair Patty Murray (D-WA) stressing the need for an experienced leader, like Califf, who can ensure that science comes first.
A Boston-based provider of lab space is tripling its footprint with the addition of a West Coast campus.
SmartLabs, a company with labs in three different neighborhoods in the Boston area, will open a new research and manufacturing center that will be located in the heart of the South San Francisco biotech corridor. The site will support end-to-end drug development and include 500L manufacturing bioreactors that can support allogeneic and autologous cell therapies.
As the investments in cell and gene therapy manufacturing continue to grow across the world, Cincinnati Children’s Hospital and CTI Clinical Trial & Consulting Services have entered a $100 million agreement to produce clinical material locally.
The joint venture enables the hospital to work on its Translational Core Laboratory, which manufactures and tests services for cell and gene therapy trials. This will help address the global gene and cell therapy shortage and prevent the lack of capacity from getting in the way of new development. About 15 C&G therapy products have been approved by regulatory agencies across the globe, and a study from the Alliance for Regenerative Medicine predicts another 10 to 20 per year by 2025.
Sanofi head of development Dietmar Berger
Sanofi’s fitusiran has had a rough road in hemophilia, weathering clinical holds and program halts tied to its lingering safety woes. Now, the drug is nearing the finish line with late-stage data in hand, but will those same safety concerns slam the brakes on the program despite its deliriously effective results?
Fitusiran, an RNAi drug designed to silence the gene that overproduces a protein responsible for clotting suppression, significantly reduced the annualized rate of bleeding over on-demand factor therapy in hemophilia A/B patients without preexisting factor inhibitors in the blood, according to late-breaking data presented Tuesday at #ASH21.
Aamir Malik, Pfizer chief business innovation officer
Pfizer made a big splash in the M&A space Monday, announcing a $6.7 billion buyout of Arena Pharmaceuticals to chase Bristol Myers Squibb in the S1P race. But company execs suggested the company isn’t finished bringing on new assets.
In an investor call outlining the Arena acquisition, chief business innovation officer Aamir Malik took a moment to discuss Pfizer’s growth plans going forward. The strategy was made up of three pillars: advancing the internal pipeline, continuing to pursue outside opportunities and exploring the combination of technology and data to ‘accelerate’ growth.
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The current generation of cell therapies has proven a game changer in terms of treating aggressive blood cancers, but the tech has its limitations. Novartis, one of the biggies in the current generation of these drugs, is now taking lessons learned from CAR-T Kymriah to supercharge a ‘second-generation’ of CAR-Ts putting superior cells into patients faster.
Novartis on Monday rolled out early Phase I data for a pair of autologous CAR-T cell therapies developed through the drugmaker’s T-Charge platform, a process designed to promote T cell ‘stemness’ — a measure of a cell’s ability to self-renew — by cutting manufacturing times and spurring cell proliferation primarily in patients’ lymph nodes.
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The drastic difference in efficacy for Merck’s Covid-19 pill between interim and final analyses — from a 50% relative reduction in hospitalizations and deaths at the interim to just 30% in the final results — had some worrying that the Pfizer pill’s early success for adults at high risk of hospitalization might also be more muted in the final results.
But that wasn’t the case early Tuesday as Pfizer said that final data available from the more than 2,200 high-risk patients enrolled in its trial confirmed prior results showing Paxlovid reduced the risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo. The company added:
https://endpts.com/ash-roches-antibody-drug-conjugate-polivy-added-to-chemo-antibody-combo-boosts-survival-in-early-stage-lymphoma/
