Onco-NSCLC

Newsletter
Issue 1 | 1st April 2025

CONTENTS

Clinical Development CLINICAL DEVELOPMENT

AstraZeneca's Savolitinib Shows Promising
Results When Combined with Osimertinib for
EGFR-Mutant NSCLC, Targeting MET-Driven AstraZeneca's Savolitinib Shows Promising Results When Combined with
Resistance …………………..…………………………….….1
Osimertinib for EGFR-Mutant NSCLC, Targeting MET-Driven Resistance.
Johnson & Johnson’s Skincare Strategy Reduces
Toxicities in Amivantamab-Lazertinib Therapy 31st March, 2025 | Read More…
for EGFR-Mutant
NSCLC……………………………………………….……………1  Savolitinib, initially approved for MET exon 14 mutations, is now being evaluated in
combination with osimertinib to target MET-driven resistance in EGFR-mutant NSCLC.
Merck’s Pembrolizumab Plus Concurrent
Chemoradiation Shows Durable Antitumor  The SAVANNAH trial shows a 56% objective response rate and a median progression-
Activity in Unresectable Stage III
NSCLC………………………………………...….………………2 free survival of 7.4 months, offering a new treatment option for patients progressing
after first-line EGFR therapy.
Regulatory Approvals
FDA Approves Durvalumab-Based Perioperative  This combination therapy expands Savolitinib’s market potential and could generate an
Regimen for Muscle-Invasive Bladder Cancer,
Marking a New Standard of
additional $1–2 billion annually if approved globally.
Care………………………………………………..…………….2  Safety concerns include a 57% incidence of grade 3+ adverse events, necessitating
FDA Grants Approval to Exelixis’ Cabometyx for careful management to maintain clinician confidence and patient adherence.
Advanced Neuroendocrine Tumors, Setting a
New Standard of Care Across Pancreatic and
 Savolitinib's approval would position it as one of the few therapies addressing MET-
Extra-Pancreatic ……………………………………………. driven resistance in NSCLC, differentiating it from chemotherapy-based treatments.
……………..…...……2

Sanofi's Qfitlia (Fitusiran) Receives FDA

Approval as Novel Treatment for Hemophilia A Johnson & Johnson’s Skincare Strategy Reduces Toxicities in Amivantamab-
and B, Offering Significant Benefits for Patients
with or without Factor Lazertinib Therapy for EGFR-Mutant NSCLC.
Inhibitors……………………………………………………….3
1st April, 2025 | Read More…
Product Launch
 Improved Tolerability: Skincare regimen reduces skin and nail toxicities, enhancing
FDA Expands Novartis Pluvicto’s Indication for
Earlier Use in PSMA-Positive mCRPC, Setting a patient adherence and treatment duration.
New Benchmark in Radioligand Therapy….
………………………………….………..…………3  Market Differentiation: This approach distinguishes amivantamab-lazertinib from
competitors in EGFR-mutant NSCLC.
Industry Update
Adicet Bio Highlights Gamma Delta CAR T Cell  Revenue Potential: Increased adoption and longer treatment durations could boost
Progress at 2025 Canaccord Oncology
Conference, Targeting Solid Tumors and
Johnson & Johnson’s revenue.
Autoimmune Diseases…………………….……………..4  Global Reach: The strategy could support regulatory approvals in markets with high
EGFR mutation prevalence, especially in Asia.
 Educational Opportunities: Johnson & Johnson can drive awareness through targeted
campaigns to promote the skincare regimen’s benefits.

1
Onco-NSCLC Merck’s Pembrolizumab Plus Concurrent Chemoradiation Shows Durable
Antitumor Activity in Unresectable Stage III NSCLC
Newsletter 1st April, 2025 | Read More…
 Strong Efficacy: Pembrolizumab plus cCRT in KEYNOTE-799 showed high response rates
Issue 1 | 1st April 2025 (71.4%-75.5%) in unresectable stage III NSCLC.
 Manageable Safety: The combination therapy had a tolerable safety profile, with grade
3+ pneumonitis in 6.9%-8.0% of patients.
 Long-Term Benefit: Median progression-free survival reached 30.6 months, reinforcing
its potential as a standard treatment.
 Market Expansion: High efficacy and safety could drive increased adoption,
strengthening pembrolizumab’s NSCLC market position.
 Revenue & Research Growth: Positive results support further clinical research and
expanded indications, boosting Merck’s commercial outlook.

REGULATORY APPROVALS
FDA Approves Durvalumab-Based Perioperative Regimen for Muscle-Invasive
Bladder Cancer, Marking a New Standard of Care.
28th March, 2025 | Read More…
 First-Mover Advantage: Only FDA-approved perioperative immunotherapy for MIBC,
strengthening AstraZeneca’s oncology leadership.
 Standard of Care Shift: NIAGARA trial showed 32% recurrence risk reduction and 25%
OS improvement, potentially redefining MIBC treatment.
 Major Market & Revenue Potential: 10,000–15,000 U.S. patients annually, $1.5B–$2B
revenue by 2030, and global expansion opportunities.
 Adoption Challenges: Physician resistance, treatment logistics, and cost-effectiveness
concerns may slow uptake.
 Strategic Execution: Focus on physician education, real-world evidence, biomarker-
driven patient selection, and lifecycle management.

FDA Grants Approval to Exelixis’ Cabometyx for Advanced Neuroendocrine

Tumors, Setting a New Standard of Care Across Pancreatic and Extra-Pancreatic
NETs.
26th March, 2025 | Read More…
 Cabozantinib’s FDA approval provides a new treatment for rare, advanced pNET and
epNET in adults and pediatrics.
 The CABINET trial showed significant efficacy, with a 59% lower risk of progression for
pNET and 60% for epNET.
 Cabozantinib offers a targeted therapy option, differentiating itself from traditional
chemotherapy.
 The approval boosts commercial growth, with global expansion and increased adoption
through education.
 Challenges include managing grade 3+ adverse events and the need for long-term
survival data.

Onco-NSCLC  Global NET market was valued at approx. $2.88 billion in 2025 and is projected to reach
around $4.89 billion by 2034, with 6.09% CAGR.

Newsletter 2
 Sanofi's Qfitlia (Fitusiran) Receives FDA Approval as Novel Treatment for
Issue 1 | 1st April 2025 Hemophilia A and B, Offering Significant Benefits for Patients with or without
Factor Inhibitors.
28th March, 2025 | Read More…
 First-in-Class Therapy: Qfitlia is the first siRNA-based therapy for hemophilia, offering a
novel mechanism to improve clotting by targeting antithrombin, distinguishing it from
traditional treatments.
 Addressing Unmet Needs: It fills a significant gap in treatment options, especially for
patients with inhibitors, potentially improving outcomes for the global hemophilia
population.
 Reduced Treatment Burden: With dosing every two months, Qfitlia offers convenience,
improving patient adherence and quality of life compared to more frequent traditional
therapies.
 Revenue Growth Potential: Given its unique mechanism and large patient base, Qfitlia
is well-positioned to capture a substantial share of the $12 billion hemophilia treatment
market.
 Safety and Competition: While offering a differentiated approach, Qfitlia must manage
risks like thrombotic events and liver toxicity while competing against established and
emerging therapies.

PRODUCT LAUNCH
FDA Expands Novartis Pluvicto’s Indication for Earlier Use in PSMA-Positive
mCRPC, Setting a New Benchmark in Radioligand Therapy.
28th March, 2025 | Read More…
 Broadened Patient Eligibility: The expanded indication triples the eligible patient
population, allowing for earlier treatment in PSMA-positive mCRPC patients.
 Shift in Treatment Paradigms: Positions Pluvicto as a first-line therapy, potentially
delaying chemotherapy and reshaping mCRPC treatment protocols.
 Strong Clinical Evidence: 59% reduction in radiographic progression risk and doubling of
progression-free survival (11.6 vs. 5.6 months) supports its use over traditional
therapies.
 Commercial Growth Potential: Novartis targets $5B peak sales for Pluvicto, with a
strong revenue growth opportunity from the expanded indication.
 Challenges & Risks: Adoption barriers from traditional therapies, safety monitoring, and
regulatory scrutiny remain key hurdles for broader uptake.

Onco-NSCLC INDUSTRY UPDATE

Newsletter
3
 Adicet Bio Highlights Gamma Delta CAR T Cell Progress at 2025 Canaccord
Oncology Conference, Targeting Solid Tumors and Autoimmune Diseases.
Issue 1 | 1st April 2025 1th April, 2025 | Read More…
 Conference Participation: Adicet Bio will present at the 2025 Canaccord Genuity
Horizons in Oncology Virtual Conference, highlighting its progress in gamma delta T cell
therapies.
 Pipeline Focus: The company will showcase ADI-001 for autoimmune diseases and ADI-
270 for solid tumors like ccRCC, with Phase 1 trial data expected in 2025.
 Market Positioning: Adicet aims to strengthen its visibility in the CAR T therapy
landscape, attracting potential investors and partners.
 Expansion Potential: Its diversified portfolio across oncology and autoimmune diseases
targets high unmet medical needs, broadening market opportunities.
 Strategic Growth: The conference provides a platform for investor engagement,
competitive positioning, and potential collaborations with major pharma companies.

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